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

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.

Timeline

Start

2001-10

Primary completion

—

Completion

2004-08

Publications

• Background Blake DD, Weathers FW, Nagy LM, Kaloupek DG, Gusman FD, Charney DS, Keane TM. The development of a Clinician-Administered PTSD Scale. J Trauma Stress. 1995 Jan;8(1):75-90. doi: 10.1007/BF02105408.
• Background Beckham JC, Lytle BL, Feldman ME. Caregiver burden in partners of Vietnam War veterans with posttraumatic stress disorder. J Consult Clin Psychol. 1996 Oct;64(5):1068-72. doi: 10.1037//0022-006x.64.5.1068.
• Background Arora RC, Fichtner CG, O'Connor F, Crayton JW. Paroxetine binding in the blood platelets of post-traumatic stress disorder patients. Life Sci. 1993;53(11):919-28. doi: 10.1016/0024-3205(93)90444-8.

Drugs

Indications