Clinical trial NCT00133822: Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial
Official title: Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Post-Traumatic Stress Disorders
Keywords: Post-Traumatic Stress Disorder
Sertraline
Risperidone
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Janssen, LP
First posted: 2005-08-24
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Remission of symptoms after 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Durham
country: United States
facility: Duke University Medical Center South
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Emory University
name: Barbara O Rothbaum, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rothbaum BO, Killeen TK, Davidson JR, Brady KT, Connor KM, Heekin MH. Placebo-controlled trial of risperidone augmentation for selective serotonin reuptake inhibitor-resistant civilian posttraumatic stress disorder. J Clin Psychiatry. 2008 Apr;69(4):520-5. doi: 10.4088/jcp.v69n0402.