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Risperidone Augmentation for PTSD

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sertraline and risperidone
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, sertraline, risperidone, antidepressant, antipsychotic, anxiety, trauma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed consent prior to any study procedures being done Male or female outpatients between 18-65 years of age Trauma experienced meets trauma defined by DSM Meets criteria for DSM-IV PTSD as a result of civilian trauma CAPS Score of greater than or equal to 50 at screening and baseline Able to swallow whole capsules Fluency in both written and spoken English Negative urine drug screen at screening visit If female of childbearing potential, must have negative serum pregnancy test at screening visit and must agree to use a medically accepted means of contraception throughout the study and for 30 days after completion of the study To be include in Phase 2, must complete Phase I and must have less than 70% reduction from baseline on the CAPS Exclusion Criteria: Pregnant women or those likely to become pregnant, or nursing mothers Medical instability (clinically significant hepatic, cardiac, or pulmonary disease, HIV, uncontrolled hypertension, diabetes or thyroid conditions, seizure disorders, clinically significant laboratory abnormalities at screen Primary psychotic disorder, or history of schizophrenia, other psychotic disorder, bipolar disorder, or cognitive disorder Those considered a risk for suicidal or homicidal behavior (the clinician will immediately, upon assessing a risk for suicidal or homicidal behavior, refer the patient for further evaluation and probable hospitalization) Hypersensitivity or other contraindication to sertraline or risperidone Meeting DSM-IV criteria for drug or alcohol dependence within 3 months of study entry Those who are still experiencing an ongoing traumatic stressor (domestic violence/elder abuse) who will need to focus on safety (the clinician will make referrals as appropriate) DSM-IV primary diagnosis of any other anxiety disorder or major depressive disorder Current use of antipsychotic, or other psychotropic medications, or supplements with known psychotropic effects Current involvement in litigation related to PTSD Current psychotherapy aimed at treating PTSD PTSD as a result of combat-related trauma Previous failure to respond to sertraline-risperidone combination at therapeutic dose

Sites / Locations

  • Emory University Medical Center
  • Medical University of South Carolina

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale (CAPS)

Secondary Outcome Measures

Davidson Trauma Scale (DTS)
Beck Depression Inventory
Quality of Life/Q-LES-Q
Connor-Davidson Resilience Scale
Clinical Global Improvement Scale (CGI-I)
Positive and Negative Symptoms Scale (PANSS)

Full Information

First Posted
September 20, 2005
Last Updated
September 18, 2014
Sponsor
Duke University
Collaborators
Janssen Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00215241
Brief Title
Risperidone Augmentation for PTSD
Official Title
Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Duke University
Collaborators
Janssen Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to (1) compare the response of civilians with Posttraumatic Stress Disorder(PTSD) currently receiving sertraline without an optimal response to risperidone augmentation vs. placebo, and (2) to evaluate the tolerability of risperidone augmentation, and (3) to identifiy predictors of response to risperidone augmentation. the hypothesis is that risperidone augmentation of sertraline treatment of PTSD is safe and effective.
Detailed Description
This is a multi-center, two-phase study to evaluate the efficacy and safety of risperidone augmentation to sertraline treatment of Post-Traumatic Stress Disorder (PTSD). In the first phase, all patients will be assigned to take open label sertraline for 8 weeks (up to 200 mg/d). Those who have not achieved a significant decrease in their PTSD symptoms by week 8 will be entered into the second phase. In the second phase, patients will continue with the sertraline, but will then be randomly given either risperidone (up to 3 mg/d) or matching placebo in double-blind fashion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
PTSD, sertraline, risperidone, antidepressant, antipsychotic, anxiety, trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sertraline and risperidone
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS)
Secondary Outcome Measure Information:
Title
Davidson Trauma Scale (DTS)
Title
Beck Depression Inventory
Title
Quality of Life/Q-LES-Q
Title
Connor-Davidson Resilience Scale
Title
Clinical Global Improvement Scale (CGI-I)
Title
Positive and Negative Symptoms Scale (PANSS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed consent prior to any study procedures being done Male or female outpatients between 18-65 years of age Trauma experienced meets trauma defined by DSM Meets criteria for DSM-IV PTSD as a result of civilian trauma CAPS Score of greater than or equal to 50 at screening and baseline Able to swallow whole capsules Fluency in both written and spoken English Negative urine drug screen at screening visit If female of childbearing potential, must have negative serum pregnancy test at screening visit and must agree to use a medically accepted means of contraception throughout the study and for 30 days after completion of the study To be include in Phase 2, must complete Phase I and must have less than 70% reduction from baseline on the CAPS Exclusion Criteria: Pregnant women or those likely to become pregnant, or nursing mothers Medical instability (clinically significant hepatic, cardiac, or pulmonary disease, HIV, uncontrolled hypertension, diabetes or thyroid conditions, seizure disorders, clinically significant laboratory abnormalities at screen Primary psychotic disorder, or history of schizophrenia, other psychotic disorder, bipolar disorder, or cognitive disorder Those considered a risk for suicidal or homicidal behavior (the clinician will immediately, upon assessing a risk for suicidal or homicidal behavior, refer the patient for further evaluation and probable hospitalization) Hypersensitivity or other contraindication to sertraline or risperidone Meeting DSM-IV criteria for drug or alcohol dependence within 3 months of study entry Those who are still experiencing an ongoing traumatic stressor (domestic violence/elder abuse) who will need to focus on safety (the clinician will make referrals as appropriate) DSM-IV primary diagnosis of any other anxiety disorder or major depressive disorder Current use of antipsychotic, or other psychotropic medications, or supplements with known psychotropic effects Current involvement in litigation related to PTSD Current psychotherapy aimed at treating PTSD PTSD as a result of combat-related trauma Previous failure to respond to sertraline-risperidone combination at therapeutic dose
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Davidson, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Rothbaum, Ph.D.
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Medical Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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Risperidone Augmentation for PTSD

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