NCT00215241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

September 22, 2014

Status Verified

June 1, 2006

First QC Date

September 20, 2005

Last Update Submit

September 18, 2014

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSDsertralinerisperidoneantidepressantantipsychoticanxietytrauma

Outcome Measures

Primary Outcomes (1)

  • Clinician Administered PTSD Scale (CAPS)

Secondary Outcomes (6)

  • Davidson Trauma Scale (DTS)

  • Beck Depression Inventory

  • Quality of Life/Q-LES-Q

  • Connor-Davidson Resilience Scale

  • Clinical Global Improvement Scale (CGI-I)

  • +1 more secondary outcomes

Interventions

sertraline and risperidoneDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University Medical Center

Atlanta, Georgia, 30322, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety DisordersWounds and Injuries

Interventions

SertralineRisperidone

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jonathan Davidson, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

  • Barbara Rothbaum, Ph.D.

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

April 1, 2004

Study Completion

July 1, 2006

Last Updated

September 22, 2014

Record last verified: 2006-06

Locations

US(2)