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| Name | Class |
|---|---|
| Janssen, LP | INDUSTRY |
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The purpose of this research of 400 participants is to determine whether a drug called risperidone can decrease symptoms of Post-Traumatic Stress Disorder (PTSD). It is a placebo-controlled study, meaning that half of the participants will be assigned to receive a pill that contains no drug. The treatment phase of the study will last for 6 months, during which time participants will continue to receive all their usual treatments in addition to the study treatment and will be asked to complete procedures and assessments (questionnaires, interviews, laboratory tests, physical exams, etc.) related to their PTSD symptoms at various points within the 6-month treatment phase. At the end of the 6-month study, participants will discontinue the study treatment.
Primary Hypothesis: Risperidone will reduce symptoms of PTSD, relative to placebo, in veterans with military service related chronic PTSD who have been partial or non-responders to antidepressant medications.
Secondary Hypothesis: Risperidone is safe and well-tolerated in veterans with military service related chronic PTSD, and patients will comply with its prescription. As a result, patients will show improvement in the secondary consequences of PTSD for the veteran and for the VA.
Intervention: Usual (PTSD) care plus Risperidone vs usual (PTSD) care plus placebo Study Abstract: Four hundred veterans with the diagnosis of military-related PTSD will be enrolled at 20 VAMC hospitals over a two-year period. An equipoise stratification design will be used to randomize patients in a double-blind manner to risperidone or placebo (~200 patients in each group) for six months of treatment. Usual care will be provided for all patients for treatment of PTSD and other psychiatric and medical disorders. Comparisons between the risperidone and placebo groups will be made at the end of six months to answer the primary question. The sample size is calculated to give 90% power at the two-sided alpha level of 0.05 for the overall test for the CAPS score change.
STUDY UPDATE/NOTES: The study kicked-off in late July 2006 with recruitment expected to begin October 1, 2006.
Oct2006 - Participating sites are seeking approval for the protocol amendment which resulted from the Kick-Off meeting. Patient recruitment at each site will begin as soon as they receive approval of the amendment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risperidone | Active Comparator | 1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day |
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| Sugar Pill | Placebo Comparator | Placebo 1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Drug | Initiate treatment with a low dose (1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day). Reduction to a lower dose will be allowed at any time, based on adverse effects. Treatment will continue for 6 months. Patients who discontinue treatment will be allowed to resume treatment at any time. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CAPS Score From Baseline to Week 24 | The primary outcome measure for this study was the total score on the 34-item Clinician-Administered PTSD Scale (CAPS). This study was the intent-to-treat analysis of the improvement in PTSD symptoms from baseline to week-24 follow-up as measured by the CAPS. Total score range for the CAPS is 0-136 with higher values representing a worse outcome. This study was powered initially to detect a 9-point difference between the treatment groups in the CAPS change score. | 24 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John H. Krystal | VA Connecticut Health Care System (West Haven) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Tuscaloosa | Tuscaloosa | Alabama | 35404 | United States | ||
| VA San Diego Healthcare System, San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26890894 | Derived | Krystal JH, Pietrzak RH, Rosenheck RA, Cramer JA, Vessicchio J, Jones KM, Huang GD, Vertrees JE, Collins J, Krystal AD; Veterans Affairs Cooperative Study #504 Group. Sleep disturbance in chronic military-related PTSD: clinical impact and response to adjunctive risperidone in the Veterans Affairs cooperative study #504. J Clin Psychiatry. 2016 Apr;77(4):483-91. doi: 10.4088/JCP.14m09585. | |
| 21813427 |
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Patients were recruited initially from 20 VA Medical Centers over a 2-year period. To address low recruitment rates and other issues, 8 sites were discontinued and 6 sites were added during the course of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Risperidone | an atypical antipsychotic indicated for the treatment of schizophrenia but not for Post Traumatic Stress Disorder (PTSD). Some of additional unlabeled uses of risperidone include behavioral symptoms associated with dementia in the elderly, bipolar disorder, Tourette's disorder, pervasive developmental disorder and autism. (1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Placebo |
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| San Diego |
| California |
| 92161 |
| United States |
| VA Medical Center, San Francisco | San Francisco | California | 94121 | United States |
| VA Greater Los Angeles Healthcare System, West LA | West Los Angeles | California | 90073 | United States |
| VA Connecticut Health Care System (West Haven) | West Haven | Connecticut | 06516 | United States |
| VA Medical Center, Miami | Miami | Florida | 33125 | United States |
| Atlanta VA Medical and Rehab Center, Decatur | Decatur | Georgia | 30033 | United States |
| Jesse Brown VAMC (WestSide Division) | Chicago | Illinois | 60612 | United States |
| VA Maryland Health Care System, Baltimore | Baltimore | Maryland | 21201 | United States |
| VA Medical Center, Jamaica Plain Campus | Boston | Massachusetts | 02130 | United States |
| VA Medical Center, Minneapolis | Minneapolis | Minnesota | 55417 | United States |
| New Mexico VA Health Care System, Albuquerque | Albuquerque | New Mexico | 87108-5153 | United States |
| VA Medical Center, Durham | Durham | North Carolina | 27705 | United States |
| VA Medical Center, Providence | Providence | Rhode Island | 02908 | United States |
| Ralph H Johnson VA Medical Center, Charleston | Charleston | South Carolina | 29401-5799 | United States |
| Michael E. DeBakey VA Medical Center (152) | Houston | Texas | 77030 | United States |
| VA South Texas Health Care System, San Antonio | San Antonio | Texas | 78229 | United States |
| Central Texas Veterans Health Care System | Temple | Texas | 76504 | United States |
| VA Salt Lake City Health Care System, Salt Lake City | Salt Lake City | Utah | 84148 | United States |
| Wlliam S. Middleton Memorial Veterans Hospital, Madison | Madison | Wisconsin | 53705 | United States |
| Derived |
| 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. |
| FG001 | Sugar Pill | Placebo Sugar Pill 1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day). |
| COMPLETED |
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| NOT COMPLETED |
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Valid diagnostic baseline data were collected on 267 patients randomized to receive risperidone (n=133) and placebo (n=134). The 29 patients with "missing source documents" as reported in Participant Flow were not included in any analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Risperidone | Risperidone : atypical antipsychotic |
| BG001 | Sugar Pill | PTSD Placebo : Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in CAPS Score From Baseline to Week 24 | The primary outcome measure for this study was the total score on the 34-item Clinician-Administered PTSD Scale (CAPS). This study was the intent-to-treat analysis of the improvement in PTSD symptoms from baseline to week-24 follow-up as measured by the CAPS. Total score range for the CAPS is 0-136 with higher values representing a worse outcome. This study was powered initially to detect a 9-point difference between the treatment groups in the CAPS change score. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 24 Weeks |
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Within 72 hours of site being made aware of event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Risperidone | Risperidone : atypical antipsychotic | 16 | 133 | 0 | 133 | ||
| EG001 | Sugar Pill | PTSD Placebo : Placebo | 10 | 134 | 0 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Gastrooesphageal reflus Disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Intestinal Obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Non-cardiac | General disorders | MedDRA | Systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Pulmonary | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Infections | Infections and infestations | MedDRA | Systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Krystal, MD | VA Connecticut HCS | 203-937-4790 | john.krystal@yale.edu |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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| Male |
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