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Completed

NCT Number: NCT00133822

Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial

The purpose of this study is to determine whether the administration of risperidone is effective in the treatment of selective serotonin reuptake inhibitor (SSRI)-resistant post-traumatic stress disorder (PTSD) in civilians.

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Key information

Conditions

Post-Traumatic Stress Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Emory University School of Medicine, Atlanta, Georgia, United States

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About this study

Individuals with PTSD often experience anxiety attacks, nightmares, or repeated unwanted memories after experiencing or witnessing life-threatening events, such as serious accidents or natural disasters, or traumatic events such as physical or sexual abuse.

Risperidone has been approved by the Food and Drug Administration for the treatment of psychotic disorders and has been found helpful for PTSD and depression, but is still considered investigational for the purposes of this study.

All qualified participants will be started on sertraline (Zoloft) for eight weeks. Patients who are still symptomatic at the end of this phase, will be invited to join the second portion of the study where they will be randomly assigned to receive risperidone or placebo (sugar pill) in addition to the sertraline. Participants will be monitored regularly for medication effects, adverse events, and PTSD symptoms.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meets criteria for DSM-IV PTSD for a minimum of one month duration
  • Clinician-Administered PTSD Scale (CAPS) score > or = to 50
  • Able to read and complete questionnaires and interviews
  • Negative urine drug screen

Exclusion criteria

  • Pregnant or nursing
  • Primary psychotic disorder; psychotic disorder; or cognitive disorder.
  • Prominent suicidal or homicidal ideation
  • Alcohol or substance dependence within 3 months of starting study
  • Primary anxiety disorder or bipolar disorder
  • Patients currently being treated with antipsychotic medication
  • Patients in active psychotherapy aimed at PTSD
  • Combat-related PTSD

Treatment and study plan

Sertraline and Risperidone

Drug

Primary outcomes

  1. Remission of symptoms after 16 weeks

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Janssen, LP

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Aug 24, 2005
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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