Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-02-28 @ 8:47 PM
Study NCT ID:
NCT01917318
Status:
TERMINATED
Last Update Posted:
2020-02-11
First Post:
2013-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Iloperidone for Symptoms of Arousal in Post Traumatic Stress Disorder (PTSD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081732', 'term': 'iloperidone'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Michael.Allen@ucdenver.edu', 'phone': '(303) 724-3300', 'title': 'Michael H. Allen, M.D.', 'organization': 'University of Colorado'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Study was terminated due to lack of enrollment. No participants were enrolled in the "Iloperidone / Placebo" arm', 'eventGroups': [{'id': 'EG000', 'title': 'Iloperidone / Placebo', 'description': 'During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo / Iloperidone', 'description': 'During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Clinician Administered PTSD Scale (CAPS) Part B and D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iloperidone / Placebo', 'description': 'During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}, {'id': 'OG001', 'title': 'Placebo / Iloperidone', 'description': 'During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}], 'classes': [{'title': 'CAPS part B at randomization 1', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'CAPS part B after 8 weeks with placebo', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'CAPS part B at randomization 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'CAPS part B after 2 weeks with iloperidone', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'CAPS part D at randomization 1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'CAPS part D after 8 weeks with placebo', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'CAPS part D at randomization 2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'CAPS part D after 2 weeks with iloperidone', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization and at the end of each treatment period. Placebo treatment lasted 8 weeks. Iloperidone treatment lasted 2 weeks.', 'description': 'The Clinician-Administered PTSD Scale (CAPS) is a structured interview used to diagnose and assess PTSD. Part B of CAPS evaluates symptoms of re-experiencing. Part D evaluates avoidance and numbing.\n\nCAPS-B scores range from 0 to 40 where higher scores indicate more symptoms. A score 0 means no re-experiencing symptoms.\n\nCAPS-D scores range form 0 to 56 and higher scores indicate more symptoms. A score 0 means no avoidance or numbing symptoms.\n\nThe primary endpoint was changes in CAPS part B and D after 8 weeks of treatment.', 'unitOfMeasure': 'units on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated due to lack of enrollment.'}, {'type': 'SECONDARY', 'title': 'Number of Awakenings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iloperidone / Placebo', 'description': 'During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}, {'id': 'OG001', 'title': 'Placebo / Iloperidone', 'description': 'During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}], 'classes': [{'title': 'Number of awakening at randomization'}, {'title': 'Number of awakening during placebo treatment'}, {'title': 'Number of awakening during iloperidone treatment'}], 'timeFrame': 'Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .', 'description': 'Number of awakenings was measured by wrist actigraphy and sleep logs. Actigraphy results were downloaded at each study visit. The mean value during placebo treatment was calculated. There was only 1 value during iloperidone treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated due to lack of enrollment. No data for this outcome measure was collected for the single participant.'}, {'type': 'SECONDARY', 'title': 'Aggression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iloperidone / Placebo', 'description': 'During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}, {'id': 'OG001', 'title': 'Placebo / Iloperidone', 'description': 'During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}], 'classes': [{'title': 'MOAS at randomization 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'MOAS after 8 weeks with placebo', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'MOAS at randomization 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'MOAS after 2 weeks with iloperidone treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization and 8 weeks of treatment, during both treatment periods', 'description': 'Aggression was measured by the Modified Overt Aggression Scale (MOAS).This assessment measures four types of aggressive behavior (verbal, aggression against property, autoaggression, and physical aggression) . Total scores on the MOAS range from 0-40, with a higher score indicating more aggressive behavior.', 'unitOfMeasure': 'units on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated due to lack of enrollment. No data for this outcome measure was collected for the Iloperidone / Placebo arm.'}, {'type': 'SECONDARY', 'title': 'Sleep Latency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iloperidone / Placebo', 'description': 'During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}, {'id': 'OG001', 'title': 'Placebo / Iloperidone', 'description': 'During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}], 'classes': [{'title': 'Sleep latency at randomization'}, {'title': 'Sleep latency during placebo treatment'}, {'title': 'Sleep latency during iloperidone treatment'}], 'timeFrame': 'Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .', 'description': 'Sleep latency was measured by wrist actigraphy and sleep logs. Actigraphy results were downloaded at each study visit. The mean value during placebo treatment was calculated.There was only 1 value during iloperidone treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated due to lack of enrollment. No data for this outcome measure was collected for the single participant.'}, {'type': 'SECONDARY', 'title': 'Wake-time After Sleep Onset (WASO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iloperidone / Placebo', 'description': 'During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}, {'id': 'OG001', 'title': 'Placebo / Iloperidone', 'description': 'During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}], 'classes': [{'title': 'WASO at randomization'}, {'title': 'WASO during placebo treatment'}, {'title': 'WASO durinhg iloperidone treatment'}], 'timeFrame': 'Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .', 'description': 'WASO was measured by wrist actigraphy and sleep logs. Actigraphy results were downloaded at each study visit. The mean value during placebo treatment was calculated.There was only 1 value during iloperidone treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated due to lack of enrollment. No data for this outcome measure was collected for the single participant.'}, {'type': 'SECONDARY', 'title': 'Suicidal Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iloperidone / Placebo', 'description': 'During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}, {'id': 'OG001', 'title': 'Placebo / Iloperidone', 'description': 'During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}], 'classes': [{'title': 'Lifetime suicidal ideation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}, {'title': '1 month prior to screening', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal ideation during the study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Total course of the study. CSSRS was administered during each study visit. Suicidal ideation during lifetime and during the month prior to screening were also explored', 'description': 'The presence of suicidal ideation was monitored over the course of the trial by the first section of the Columbia Suicide Severity Rating Scale (CSSRS). This first section of the scale consists of 5 questions that can be answered yes or no. The number of participants who reported experiencing suicidal ideation is reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early due to lack of enrollment.'}, {'type': 'SECONDARY', 'title': 'Intensity of Suicidal Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iloperidone / Placebo', 'description': 'During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}, {'id': 'OG001', 'title': 'Placebo / Iloperidone', 'description': 'During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Intensity of Suicidal Ideation was monitored over the course of the trial by the second section of the Columbia Suicide Severity Rating Scale (CSSRS). This section is only administered if the patient answers yes to the first section. The section consists of 5 questions that refer to the most severe level of ideation endorsed in the first section of the CSSRS. The total score ranges from 2 to 25, with a higher number indicating more intense ideation and greater risk.\n\nOnly lifetime intensity of suicidal ideation was explored as the patient had no suicidal ideation from the month prior to beginning the study to the completion of the study', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early due to lack of enrollment.'}, {'type': 'SECONDARY', 'title': 'Suicidal Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iloperidone / Placebo', 'description': 'During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}, {'id': 'OG001', 'title': 'Placebo / Iloperidone', 'description': 'During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}], 'classes': [{'title': 'Lifetime suicidal behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': '1 month prior ro screening', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'During the course of the study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Total course of the study. CSSRS was administered during each study visit. Suicidal ideation during lifetime and during the month prior to screening were also explored', 'description': 'The presence and severity os suicidal behavior was monitored over the course of the trial by the third section of the Columbia Suicide Severity Rating Scale (CSSRS). This sections consists of questions about 5 suicidal behaviors and non-suicidal self injurious behavior and it can be answered yes or no. The number of participants who experienced suicidal behavior is reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated due to lack of enrollment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Iloperidone / Placebo', 'description': 'During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}, {'id': 'FG001', 'title': 'Placebo / Iloperidone', 'description': 'During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}], 'periods': [{'title': 'First Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A single participant was enrolled but did not complete the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Iloperidone / Placebo', 'description': 'During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}, {'id': 'BG001', 'title': 'Placebo / Iloperidone', 'description': 'During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.\n\nIloperidone: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)\n\nPlacebo: During 8 weeks subjects will receive oral placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline Demographics information is not reported for the single study participant to protect confidentiality.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Enrollment challenges - Single participant discontinued after placebo, no relevant outcome measure data was recorded.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-31', 'studyFirstSubmitDate': '2013-07-31', 'resultsFirstSubmitDate': '2015-11-23', 'studyFirstSubmitQcDate': '2013-08-02', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-21', 'studyFirstPostDateStruct': {'date': '2013-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Clinician Administered PTSD Scale (CAPS) Part B and D', 'timeFrame': 'Randomization and at the end of each treatment period. Placebo treatment lasted 8 weeks. Iloperidone treatment lasted 2 weeks.', 'description': 'The Clinician-Administered PTSD Scale (CAPS) is a structured interview used to diagnose and assess PTSD. Part B of CAPS evaluates symptoms of re-experiencing. Part D evaluates avoidance and numbing.\n\nCAPS-B scores range from 0 to 40 where higher scores indicate more symptoms. A score 0 means no re-experiencing symptoms.\n\nCAPS-D scores range form 0 to 56 and higher scores indicate more symptoms. A score 0 means no avoidance or numbing symptoms.\n\nThe primary endpoint was changes in CAPS part B and D after 8 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Number of Awakenings', 'timeFrame': 'Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .', 'description': 'Number of awakenings was measured by wrist actigraphy and sleep logs. Actigraphy results were downloaded at each study visit. The mean value during placebo treatment was calculated. There was only 1 value during iloperidone treatment.'}, {'measure': 'Aggression', 'timeFrame': 'Randomization and 8 weeks of treatment, during both treatment periods', 'description': 'Aggression was measured by the Modified Overt Aggression Scale (MOAS).This assessment measures four types of aggressive behavior (verbal, aggression against property, autoaggression, and physical aggression) . Total scores on the MOAS range from 0-40, with a higher score indicating more aggressive behavior.'}, {'measure': 'Sleep Latency', 'timeFrame': 'Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .', 'description': 'Sleep latency was measured by wrist actigraphy and sleep logs. Actigraphy results were downloaded at each study visit. The mean value during placebo treatment was calculated.There was only 1 value during iloperidone treatment'}, {'measure': 'Wake-time After Sleep Onset (WASO)', 'timeFrame': 'Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .', 'description': 'WASO was measured by wrist actigraphy and sleep logs. Actigraphy results were downloaded at each study visit. The mean value during placebo treatment was calculated.There was only 1 value during iloperidone treatment.'}, {'measure': 'Suicidal Ideation', 'timeFrame': 'Total course of the study. CSSRS was administered during each study visit. Suicidal ideation during lifetime and during the month prior to screening were also explored', 'description': 'The presence of suicidal ideation was monitored over the course of the trial by the first section of the Columbia Suicide Severity Rating Scale (CSSRS). This first section of the scale consists of 5 questions that can be answered yes or no. The number of participants who reported experiencing suicidal ideation is reported.'}, {'measure': 'Intensity of Suicidal Ideation', 'timeFrame': 'Baseline', 'description': 'Intensity of Suicidal Ideation was monitored over the course of the trial by the second section of the Columbia Suicide Severity Rating Scale (CSSRS). This section is only administered if the patient answers yes to the first section. The section consists of 5 questions that refer to the most severe level of ideation endorsed in the first section of the CSSRS. The total score ranges from 2 to 25, with a higher number indicating more intense ideation and greater risk.\n\nOnly lifetime intensity of suicidal ideation was explored as the patient had no suicidal ideation from the month prior to beginning the study to the completion of the study'}, {'measure': 'Suicidal Behavior', 'timeFrame': 'Total course of the study. CSSRS was administered during each study visit. Suicidal ideation during lifetime and during the month prior to screening were also explored', 'description': 'The presence and severity os suicidal behavior was monitored over the course of the trial by the third section of the Columbia Suicide Severity Rating Scale (CSSRS). This sections consists of questions about 5 suicidal behaviors and non-suicidal self injurious behavior and it can be answered yes or no. The number of participants who experienced suicidal behavior is reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Post traumatic stress disorder', 'Treatment of post traumatic stress disorder', 'Symptoms of arousal in post traumatic stress disorder', 'Iloperidone in post traumatic stress disorder'], 'conditions': ['Post Traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '19624791', 'type': 'BACKGROUND', 'citation': 'Citrome L. Iloperidone for schizophrenia: a review of the efficacy and safety profile for this newly commercialised second-generation antipsychotic. Int J Clin Pract. 2009 Aug;63(8):1237-48. doi: 10.1111/j.1742-1241.2009.02142.x.'}, {'pmid': '16845653', 'type': 'BACKGROUND', 'citation': 'David D, De Faria L, Mellman TA. Adjunctive risperidone treatment and sleep symptoms in combat veterans with chronic PTSD. Depress Anxiety. 2006;23(8):489-91. doi: 10.1002/da.20187.'}, {'pmid': '21813427', 'type': 'BACKGROUND', 'citation': 'Krystal JH, Rosenheck RA, Cramer JA, Vessicchio JC, Jones KM, Vertrees JE, Horney RA, Huang GD, Stock C; Veterans Affairs Cooperative Study No. 504 Group. Adjunctive risperidone treatment for antidepressant-resistant symptoms of chronic military service-related PTSD: a randomized trial. JAMA. 2011 Aug 3;306(5):493-502. doi: 10.1001/jama.2011.1080.'}, {'pmid': '17521374', 'type': 'BACKGROUND', 'citation': 'Kobayashi I, Boarts JM, Delahanty DL. Polysomnographically measured sleep abnormalities in PTSD: a meta-analytic review. Psychophysiology. 2007 Jul;44(4):660-9. doi: 10.1111/j.1469-8986.2007.537.x. Epub 2007 May 22.'}, {'pmid': '12640221', 'type': 'BACKGROUND', 'citation': 'Monnelly EP, Ciraulo DA, Knapp C, Keane T. Low-dose risperidone as adjunctive therapy for irritable aggression in posttraumatic stress disorder. J Clin Psychopharmacol. 2003 Apr;23(2):193-6. doi: 10.1097/00004714-200304000-00012.'}, {'pmid': '17069768', 'type': 'BACKGROUND', 'citation': "Raskind MA, Peskind ER, Hoff DJ, Hart KL, Holmes HA, Warren D, Shofer J, O'Connell J, Taylor F, Gross C, Rohde K, McFall ME. A parallel group placebo controlled study of prazosin for trauma nightmares and sleep disturbance in combat veterans with post-traumatic stress disorder. Biol Psychiatry. 2007 Apr 15;61(8):928-34. doi: 10.1016/j.biopsych.2006.06.032. Epub 2006 Oct 25."}, {'pmid': '15641864', 'type': 'BACKGROUND', 'citation': 'Reich DB, Winternitz S, Hennen J, Watts T, Stanculescu C. A preliminary study of risperidone in the treatment of posttraumatic stress disorder related to childhood abuse in women. J Clin Psychiatry. 2004 Dec;65(12):1601-6. doi: 10.4088/jcp.v65n1204.'}, {'pmid': '17868655', 'type': 'BACKGROUND', 'citation': 'Taylor FB, Martin P, Thompson C, Williams J, Mellman TA, Gross C, Peskind ER, Raskind MA. Prazosin effects on objective sleep measures and clinical symptoms in civilian trauma posttraumatic stress disorder: a placebo-controlled study. Biol Psychiatry. 2008 Mar 15;63(6):629-32. doi: 10.1016/j.biopsych.2007.07.001. Epub 2007 Sep 14.'}, {'pmid': '10875190', 'type': 'BACKGROUND', 'citation': 'Wicklow A, Espie CA. Intrusive thoughts and their relationship to actigraphic measurement of sleep: towards a cognitive model of insomnia. Behav Res Ther. 2000 Jul;38(7):679-93. doi: 10.1016/s0005-7967(99)00136-9.'}]}, 'descriptionModule': {'briefSummary': 'A Double-Blind Placebo-Controlled Random Order Crossover Pilot Study of Iloperidone for Symptoms of Arousal in PTSD.', 'detailedDescription': 'During Period A, subjects will receive 8 weeks of iloperidone or placebo (2 weeks titration period followed by 6 weeks on stable dose). Then they will be reassessed for response during Period A; study drug will be discontinued and washed out over the following 2 weeks. They will then begin Period B on the alternate blinded treatment with similar titration and assessment, initially weekly and then every other week for a total of another 8 weeks. The purpose of the study is to determine whether Iloperidone is effective in the treatment of some symptoms in patients with PTSD, particularly difficulty falling or staying asleep, trauma dreams and daytime irritability or outbursts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PTSD diagnosis\n\nExclusion Criteria:\n\n* Pregnancy\n* Traumatic Brain Injury greater than mild\n* Primary sleep disorder\n* Caffeinism\n* Active substance use disorder\n* Active suicidal risk\n* Antipsychotic medication, antibiotics, sedatives, some antihypertensive or antiarrhythmic medication'}, 'identificationModule': {'nctId': 'NCT01917318', 'briefTitle': 'Iloperidone for Symptoms of Arousal in Post Traumatic Stress Disorder (PTSD)', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled Random Order Crossover Study of Iloperidone for Symptoms of Arousal in PTSD Including Insomnia and Irritability.', 'orgStudyIdInfo': {'id': '13-0207'}, 'secondaryIdInfos': [{'id': 'IIRP-1371', 'type': 'OTHER', 'domain': 'Novartis pharmaceuticals'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iloperidone / Placebo', 'description': 'During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.', 'interventionNames': ['Drug: Iloperidone', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo / Iloperidone', 'description': 'During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.', 'interventionNames': ['Drug: Iloperidone', 'Drug: Placebo']}], 'interventions': [{'name': 'Iloperidone', 'type': 'DRUG', 'otherNames': ['Fanapt', 'Fanapta', 'Zomaril'], 'description': 'Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.\n\nDuring the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)', 'armGroupLabels': ['Iloperidone / Placebo', 'Placebo / Iloperidone']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar pill'], 'description': 'During 8 weeks subjects will receive oral placebo', 'armGroupLabels': ['Iloperidone / Placebo', 'Placebo / Iloperidone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Depression Center; Clinical and Translational Research Center (CTRC)', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Michael H Allen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado School of Medicine - Depression Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}