Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025740
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-10-16
Brief Title:
Clonazepam and Paroxetine for Rapid Treatment of Post-Traumatic Stress Disorder
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status Verified Date:
2004-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-M-0015 | None | None | None |