Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-25 @ 3:33 PM
Study NCT ID:
NCT01221792
Status:
UNKNOWN
Last Update Posted:
2011-06-08
First Post:
2010-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carvedilol Versus Placebo for Treatment in Post Traumatic Stress Disorder (PTSD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2011-09-01', 'unreleaseDateUnknown': True}, {'resetDate': '2011-10-31', 'releaseDate': '2011-09-23'}, {'resetDate': '2012-03-09', 'releaseDate': '2012-02-08'}, {'resetDate': '2012-11-14', 'releaseDate': '2012-10-15'}, {'resetDate': '2014-08-27', 'releaseDate': '2014-08-14'}], 'estimatedResultsFirstSubmitDate': '2011-09-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D006987', 'term': 'Hypesthesia'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077261', 'term': 'Carvedilol'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-06', 'studyFirstSubmitDate': '2010-10-14', 'studyFirstSubmitQcDate': '2010-10-14', 'lastUpdatePostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Davidson Trauma Scale (DTS)', 'timeFrame': '5 weeks', 'description': 'The DTS is a 17-item self report measure to assess the 17 DMS-IV symptoms of PTSD. Respondants are asked to identify the trauma that is most disturbing to them and to rate, in the past week, how much trouble they hav had with each symptom. The DTS can be used to make a preliminatry determination about whether the symptoms meet DSM criteria for PTSD, or scores can be calculated for each of the 3 PTSD symptom clusters.\n\nThe DTS will be assessed at each study visit (visit 1, 2, 3, 4, 5, 6 and 7). The primary efficacy outcome will be change from baseline (visit 2) to week 5 (visit 7).'}], 'secondaryOutcomes': [{'measure': 'Clinician Administered PTSD Scale (CAPS)', 'timeFrame': '6 Weeks', 'description': 'The CAPS was developed at the National Center for PTSD and has become the "gold standard" for assessing Post Traumatic Stress Disorder. It is a user-friendly structured interview for screening, differential diagnosis, comfirming PTSD diagnosis or identifying Acute Stress Disorder.\n\nThe CAPS will be assessed at the screening visit and again at week 5 (vist 7). Change scores (from screening to week 5) will be secondary efficacy measures.'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': '5 Weeks', 'description': 'The ISI is a 7-item patient rated questionnaire that evaluates severity of sleep onset and maintenance difficulties, satisfaction with current sleep pattern interference with daily functioning, appearance of impairment attributed to the sleep problem, and the degree of concern caused by insomnia.\n\nSecondary outcome measures using the ISI will be determined using change scores from baseline to week 5 (visit 7)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PTSD', 'Anxiety', 'Trauma', 'Assault', 'Victim', 'Witness', 'Post Traumatic Stress Disorder', 'Combat veteran', 'Flashbacks', 'Nightmares', 'Sleep Disturbance', 'Hyperarousal', 'Numbness', 'Avoidance'], 'conditions': ['Post-Traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that carvedilol, at less then therapeutic doses for cardiac effect, will reduce symptoms of Post Traumatic Stress Disorder.', 'detailedDescription': 'This initial proof of concept trial design is intended to explore multiple variables. Fist, it is intended to determine if carvedilol has any statistically significant effect over placebo on the various overall symptoms, symptom clusters, or individual symptoms of post traumatic stress disorder. Next, the flexible dosing trial design is aimed to detect the therapeutic dose, or dosing range for carvedilol when used in the treatment of PTSD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Post Traumatic Stress Disorder according to DSM-IV\n* Must be able to speak, read and understand the English language and be able to provide written informed consent\n\nExclusion Criteria:\n\n* current, unstable and significant medical condition/illness\n* bronchial asthma or related bronchospastic condition\n* AV block\n* Sick Sinus Syndrome\n* Bradycardia\n* Peripheral hear disease\n* Unstable thyroid disorder\n* History of seizure disorder\n* Females who are pregnant, lactating or planning to become pregnant\n* Bipolar\n* Schizophrenia\n* Dementia\n* Intolerance or hypersensitivity to alpha or beta blockers'}, 'identificationModule': {'nctId': 'NCT01221792', 'briefTitle': 'Carvedilol Versus Placebo for Treatment in Post Traumatic Stress Disorder (PTSD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Columbia Northwest Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Safety and Efficacy of Carvedilol Versus Placebo in the Treatment of Post Traumatic Stress Disorder', 'orgStudyIdInfo': {'id': 'CVD-PT-10203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'carvedilol', 'description': 'Patients randomized to carvedilol will be administered doses ranging from 6.25 to 15.625 mg/day using a flexible-dosing model. After a 1 week titration, investigators my increase daily dose by 6.25 mg/day at weeks 1 and 2 for a maximum dose of 15.625 mg/day. Weeks 3-4 will patients will remain on a stable, tolerable dose. At week 5 patients will have a 1 week taper.', 'interventionNames': ['Drug: Carvedilol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar Pill', 'description': 'Patients randomized to placebo will follow same dosing guidelines as if they were in the active comparator arm, carvedilol.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Carvedilol', 'type': 'DRUG', 'otherNames': ['Coreg(R)'], 'description': 'Oral, twice daily dosing using 3.125 mg tablets.\n\n1 week titration (6.25 mg/day)prior to a 3 week flexible dosing option ranging from 6.25 mg/day to 15.625 mg/day followed by a 1 week taper (6.25 mg/day).', 'armGroupLabels': ['carvedilol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Non active comparator', 'armGroupLabels': ['Sugar Pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '70601', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Lake Charles Clinical Trials', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Clinical Research Center', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}], 'overallOfficials': [{'name': 'Arifulla Khan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Columbia Northwest Pharmaceuticals, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia Northwest Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Arifulla Khan, MD', 'oldOrganization': 'Columbia Northwest Pharmaceuticals'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-09-01', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2011-09-23', 'type': 'RELEASE'}, {'date': '2011-10-31', 'type': 'RESET'}, {'date': '2012-02-08', 'type': 'RELEASE'}, {'date': '2012-03-09', 'type': 'RESET'}, {'date': '2012-10-15', 'type': 'RELEASE'}, {'date': '2012-11-14', 'type': 'RESET'}, {'date': '2014-08-14', 'type': 'RELEASE'}, {'date': '2014-08-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Columbia Northwest Pharmaceuticals'}}}}