Risperidone Augmentation for PTSD

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215241
• Other study ID #: 5816
• Secondary ID: 5816-05-4R1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 20, 2005
• Last updated: September 18, 2014
• Start date: April 2004
• Est. completion date: July 2006

Study information

• Verified date: June 2006
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• sertraline and risperidone

Locations

Country	Name	City	State
United States	Emory University Medical Center	Atlanta	Georgia
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Janssen Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS)
Secondary	Davidson Trauma Scale (DTS)
Secondary	Beck Depression Inventory
Secondary	Quality of Life/Q-LES-Q
Secondary	Connor-Davidson Resilience Scale
Secondary	Clinical Global Improvement Scale (CGI-I)
Secondary	Positive and Negative Symptoms Scale (PANSS)