Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT03489304
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2018-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Zaleplon in HIV Patients With Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C085665', 'term': 'zaleplon'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kayser@pennmedicine.upenn.edu', 'phone': '215 898 8298', 'title': 'Dr. Matthew Kayser', 'organization': 'Perelman School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Zaleplon', 'description': 'Open-label zaleplon 5-10mg daily\n\nZaleplon: non-benzodiazepine hypnotic agent', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insomnia Severity Index (ISI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zaleplon', 'description': 'Open-label zaleplon 5-10mg daily\n\nZaleplon: non-benzodiazepine hypnotic agent'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'spread': '4.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measure at 6 weeks', 'description': 'The Insomnia Severity Index is a validated sleep scale that measures clinical insomnia severity. The total score ranges from 0-28 where higher values indicate increased severity of insomnia.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Epworth Sleepiness Scale (ESS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zaleplon', 'description': 'Open-label zaleplon 5-10mg daily\n\nZaleplon: non-benzodiazepine hypnotic agent'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '4.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measure at 6 weeks', 'description': 'The Epworth Sleepiness Scale (ESS) is a validated sleep scale that quantifies daytime sleepiness across eight domains. The total score ranges from 0-24 where higher values indicate greater daytime sleepiness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quick Inventory of Depressive Symptomatology (QIDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zaleplon', 'description': 'Open-label zaleplon 5-10mg daily\n\nZaleplon: non-benzodiazepine hypnotic agent'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '6.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measure at 6 weeks', 'description': 'The Quick Inventory of Depressive Symptomatology (QIDS) is a validated mood scale that quantifies depression symptoms. The total score ranges from 0-48, where higher values indicate greater depressive symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zaleplon', 'description': 'Open-label zaleplon 5-10mg daily\n\nZaleplon: non-benzodiazepine hypnotic agent'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Zaleplon', 'description': 'Open-label zaleplon 5-10mg daily\n\nZaleplon: non-benzodiazepine hypnotic agent'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'spread': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '6-week open-label study evaluating zaleplon for insomnia in HIV positive patients with comorbid depression'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2015-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-18', 'studyFirstSubmitDate': '2018-03-27', 'resultsFirstSubmitDate': '2018-08-22', 'studyFirstSubmitQcDate': '2018-04-03', 'lastUpdatePostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-22', 'studyFirstPostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Measure at 6 weeks', 'description': 'The Insomnia Severity Index is a validated sleep scale that measures clinical insomnia severity. The total score ranges from 0-28 where higher values indicate increased severity of insomnia.'}], 'secondaryOutcomes': [{'measure': 'Epworth Sleepiness Scale (ESS)', 'timeFrame': 'Measure at 6 weeks', 'description': 'The Epworth Sleepiness Scale (ESS) is a validated sleep scale that quantifies daytime sleepiness across eight domains. The total score ranges from 0-24 where higher values indicate greater daytime sleepiness.'}, {'measure': 'Quick Inventory of Depressive Symptomatology (QIDS)', 'timeFrame': 'Measure at 6 weeks', 'description': 'The Quick Inventory of Depressive Symptomatology (QIDS) is a validated mood scale that quantifies depression symptoms. The total score ranges from 0-48, where higher values indicate greater depressive symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Insomnia', 'Zaleplon'], 'conditions': ['HIV/AIDS', 'Clinical Depression']}, 'descriptionModule': {'briefSummary': 'In HIV positive patients with sleep onset insomnia and receiving pharmacologic treatment for comorbid depression, the proposed study aims to evaluate the impact of zaleplon on sleep measures determined by insomnia severity index (ISI) and Epworth sleepiness scale (ESS).', 'detailedDescription': 'An estimated \\>50% of HIV positive individuals report insomnia. Insomnia and other sleep disturbances negatively impact outcomes in this population by contributing to metabolic dysfunction, reducing quality of life, and impairing psychosocial functioning. Additionally, in HIV depressed populations, insomnia may hinder remission from clinical depression. To date, there have been no pharmacotherapeutic studies treating insomnia in this population, emphasizing the need to determine whether known hypnotic medications work as effectively in HIV positive patients, including those with comorbid depression. Non-benzodiazepine hypnotics represent an attractive pharmacotherapy for treatment of insomnia in a depressed population, as there are reduced side effects and abuse potential compared to classical benzodiazepines. Consequently, an open-label study evaluating zaleplon for insomnia in HIV positive patients with comorbid depression warrants further study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects aged 18-65 years with a diagnosis of asymptomatic seropositive HIV\n2. Principal diagnosis of Major Depressive Disorder or Dysthymic Disorder in accordance with DSM-IV criteria, and receiving pharmacologic treatment.\n3. Subject has obtained some subjective benefit from current antidepressant therapy and is agreeable to remain on the same medication for the course of this study\n4. Current symptoms of insomnia as determined by a total score of at least 2 on items 4, 5, and 6 of the HAM-D, and specific complaint of sleep onset insomnia (sleep onset latency of at least 1 hour, 3 or more times per week))\n5. Free of sleep medication for at least 2 weeks prior to enrollment (we will not enroll any patients who might require weaning off of sedative hypnotic medications in order to be eligible for the study)\n6. Ability to understand the requirements of the study and provide informed consent\n\nExclusion Criteria:\n\n1. Significant chronic, systemic illness or significant neurologic disorder, including traumatic brain injury\n2. Clinically significant history of liver disease\n3. Psychiatrically unstable patients in the clinical judgment of the investigator as indicated by current acute suicidality, current homicidal thoughts, or current psychosis\n4. Lifetime history of schizophrenia, schizoaffective disorder, or any psychotic illness\n5. History of substance abuse or dependence over the past 6 months\n6. Currently taking medication to assist with sleep (e.g., Ambien/Zolpidem,Dalmane/Flurazepam, Doral/Quazepam, Halcion/Triazolam, Lunesta/Eszopiclone, Prosom/Estazolam, Restoril/Temazepam, Rozerem/Ramelteon, Sonata/Zaleplon, Melatonin, Unisom, Benadryl).\n7. Pregnant'}, 'identificationModule': {'nctId': 'NCT03489304', 'briefTitle': 'Zaleplon in HIV Patients With Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'A 6-week Open-Label Study of Treatment of Insomnia With Zaleplon in HIV Positive Patients With Comorbid Depression', 'orgStudyIdInfo': {'id': '819083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Zaleplon', 'description': 'Open-label zaleplon 5-10mg daily', 'interventionNames': ['Drug: Zaleplon']}], 'interventions': [{'name': 'Zaleplon', 'type': 'DRUG', 'description': 'non-benzodiazepine hypnotic agent', 'armGroupLabels': ['Zaleplon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29615', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mood & Anxiety Disorders Research and Treatment Program', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Matthew Kayser, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}