Clonazepam and Paroxetine for Rapid Treatment of Post-Traumatic Stress Disorder

Post Traumatic Stress Disorder Clinical Trial

Official title: Combined Treatment With a Benzodiazepine (Clonazepam) and a Selective Serotonin Reuptake Inhibitor (Paroxetine) for Rapid Treatment of Posttraumatic Stress Disorder (PTSD)

Status Completed

Clinical Trial Summary

Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that follows exposure to an extremely traumatic stressors. PTSD is associated with serious symptoms. While numerous approaches have been used to treat PTSD, these treatments have several limiting factors. This study will evaluate a combination of the drugs clonazepam and paroxetine for the treatment of PTSD symptoms.

The main goal of treatment in patients with PTSD is to significantly reduce symptom severity and improve functioning. While numerous approaches have been used to treat PTSD, these treatments are limited by variable response rates, up to a 6-week lag period before clinical response, and sub-optimal side effect profile, including possible worsening of anxiety and insomnia prior to clinical response. The proposed study will examine whether combined treatment with a benzodiazepine (clonazepam) and a selective serotonin reuptake inhibitor (paroxetine) in patients with PTSD will accelerate the onset of clinical response. A second goal is to evaluate whether the rapid and clinically meaningful benefits are sustained until the end of the study, despite tapering off the benzodiazepine at the midpoint of the study. The safety and tolerability of a combination of paroxetine and clonazepam will be compared to paroxetine and placebo (an inactive pill) in the treatment of PTSD.

Participants in this study will be randomly assigned to receive either paroxetine plus clonazepam or paroxetine plus a placebo for 12 weeks. Participants will have weekly clinic visits for the first 4 weeks of the study and every other week for the last 8 weeks. Symptoms of PTSD, anxiety, and depression will be evaluated and drug side effects will be noted during the follow-up visits.

Clinical Trial Description

Posttraumatic Stress Disorder (PTSD) is an anxiety disorder (DSM IV) (American Psychiatric Association) that follows exposure to an extremely traumatic stressor in which an individual experienced, witnessed, or was confronted with actual or threatened death or serious injury to self or others. The main goal of treatment in patients with PTSD is to significantly reduce symptom severity across reexperiencing, avoidance and hyperarousal symptoms along with improvement in function. While numerous approaches have been used to treat PTSD, these treatments are limited by variable response rates, up to a 6-week lag period prior to the onset of clinical response, and sub-optimal side effect profile, including possible worsening of anxiety and insomnia prior to clinical response.

The proposed double blind study will examine whether combined treatment with a benzodiazepine (clonazepam) and selective serotonin reuptake inhibitor (SSRI) (paroxetine) in patients with PTSD will accelerate the onset of clinical response. A second goal is to evaluate whether the rapid and clinically meaningful benefits are sustained until the end of the study, despite tapering off the benzodiazepine at the midpoint of the study. The safety and tolerability of a combination of paroxetine and clonazepam will be compared to paroxetine and placebo in the treatment of PTSD.

We hypothesize that treatment with a combination of clonazepam and paroxetine will result in a rapid reduction of PTSD symptoms compared to treatment with placebo and paroxetine. We also propose that this accelerated reduction of symptoms will be sustained until the end-point of the study, despite tapering off the benzodiazepine at the midpoint of the study. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT00025740
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: Phase 4
• Start date: October 2001
• Completion date: August 2004