Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Risperidone Augmentation for PTSD

NCT00215241

Post-Traumatic Stress Disorder

COMPLETED PHASE2/PHASE3

Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder

NCT00099983

Stress Disorders Post-Traumatic

COMPLETED PHASE2

Risperidone Augmentation Therapy in Patients Who Have Failed or Only Partially Responded to a Trial of Antidepressant

NCT00174577

Major Depression

UNKNOWN PHASE3

Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy

NCT00095134

Major Depressive Disorder

COMPLETED PHASE3

A Study of the Effectiveness and Safety of Risperidone to Augment SSRI Therapy in Patients With Treatment-resistant Depression

NCT00044681

Depressive Disorder Depressive Disorder, Major Depression

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-Traumatic Stress Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sertraline and Risperidone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes