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Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00133822
Enrollment
65
Registered
2005-08-24
Start date
2004-04-30
Completion date
2006-09-30
Last updated
2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Traumatic Stress Disorders

Keywords

Post-Traumatic Stress Disorder, Sertraline, Risperidone

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.

Interventions

Sponsors

Janssen, LP
CollaboratorINDUSTRY
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Remission of symptoms after 16 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026