Risperidone Augmentation for PTSD - Full Text View

Purpose

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.

Condition	Intervention	Phase
Post-Traumatic Stress Disorder	Drug: sertraline and risperidone	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Injuries Post-Traumatic Stress Disorder Wounds

Drug Information available for: Sertraline hydrochloride Sertraline Risperidone

U.S. FDA Resources

Further study details as provided by Duke University:

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)

Estimated Enrollment:	80
Study Start Date:	April 2004
Estimated Study Completion Date:	July 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215241

Locations

United States, Georgia
Emory University Medical Center
Atlanta, Georgia, United States, 30322
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Duke University

Janssen, LP

Investigators

Principal Investigator:	Jonathan Davidson, M.D.	Duke University
Principal Investigator:	Barbara Rothbaum, Ph.D.	Emory University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00215241 History of Changes
Other Study ID Numbers:	5816-05-4R1
Study First Received:	September 20, 2005
Last Updated:	December 18, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duke University:

PTSD
sertraline
risperidone
antidepressant

antipsychotic
anxiety
trauma

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Risperidone
Sertraline
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013