Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031317
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-02-28
Brief Title:
Evaluation of Clonazepam and Paroxetine for Panic Disorder With Depression
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 Panic Disorder With Depression
Status:
COMPLETED
Status Verified Date:
2005-06
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:
The purpose of this study is to examine the safety and effectiveness of the drug combination paroxetine and clonazepam in treating people with panic disorder PD and major depression
The main goal in treating people with PD is to rapidly reduce symptom severity and improve functioning While numerous drug therapies have been used to treat PD these treatments are limited by variable response rates and suboptimal side effect profiles Evidence suggests that clonazepam given with a selective serotonin reuptake inhibitor SSRI can facilitate a rapid reduction in PD symptoms However it is unclear whether comorbid depression influences treatment response to the clonazepam and SSRI regimen This study will examine whether combined treatment with clonazepam and the SSRI paroxetine will accelerate clinical response in participants with PD and comorbid depression This study will also examine whether the benefits of treatment will be sustained until the end of the study despite tapering of clonazepam at the midpoint of the study
Participants in this study will be screened with medical and psychiatric interviews a physical examination electrocardiogram ECG and blood tests Participants will then be randomly assigned to receive either paroxetine plus clonazepam or paroxetine plus placebo an inactive pill for 12 weeks Participants will have weekly clinic visits during which symptoms and drug side effects will be checked and an interview to evaluate panic disorder and depression symptoms will be conducted
The main goal in treating people with PD is to rapidly reduce symptom severity and improve functioning While numerous drug therapies have been used to treat PD these treatments are limited by variable response rates and suboptimal side effect profiles Evidence suggests that clonazepam given with a selective serotonin reuptake inhibitor SSRI can facilitate a rapid reduction in PD symptoms However it is unclear whether comorbid depression influences treatment response to the clonazepam and SSRI regimen This study will examine whether combined treatment with clonazepam and the SSRI paroxetine will accelerate clinical response in participants with PD and comorbid depression This study will also examine whether the benefits of treatment will be sustained until the end of the study despite tapering of clonazepam at the midpoint of the study
Participants in this study will be screened with medical and psychiatric interviews a physical examination electrocardiogram ECG and blood tests Participants will then be randomly assigned to receive either paroxetine plus clonazepam or paroxetine plus placebo an inactive pill for 12 weeks Participants will have weekly clinic visits during which symptoms and drug side effects will be checked and an interview to evaluate panic disorder and depression symptoms will be conducted
Detailed Description:
The main goal of treatment in patients with Panic Disorder PD is to effect a rapid reduction in symptom severity and improve functioning While numerous pharmacological approaches have been used to treat PD 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
There is recent evidence that the benzodiazepine clonazepam prescribed with selective serotonin reuptake inhibitors SSRI can facilitate a rapid reduction of symptoms in PD The improvement in symptoms was maintained despite tapering the clonazepam prior to the end of the study However it was unclear if co-morbid depression influenced the treatment response to this regimen In addition a recent study in patients with major depression demonstrated that combined fluoxetine-clonazepam treatment resulted in a more rapid antidepressant response than the fluoxetine-placebo combination
The proposed study will examine whether combined treatment with a clonazepam and paroxetine in patients with PD and comorbid depression will accelerate the onset of clinical response at both panic and depression symptoms PD with comorbid major depression is a more severe disorder than PD alone We will also examine whether the rapid and clinically meaningful benefits will be sustained until the end of the study despite tapering off clonazepam at the midpoint of the study If this study turns out to be the case combined SSRI-benzodiazepine treatment may become a standard initial therapeutic approach to PD and comorbid major depression
There is recent evidence that the benzodiazepine clonazepam prescribed with selective serotonin reuptake inhibitors SSRI can facilitate a rapid reduction of symptoms in PD The improvement in symptoms was maintained despite tapering the clonazepam prior to the end of the study However it was unclear if co-morbid depression influenced the treatment response to this regimen In addition a recent study in patients with major depression demonstrated that combined fluoxetine-clonazepam treatment resulted in a more rapid antidepressant response than the fluoxetine-placebo combination
The proposed study will examine whether combined treatment with a clonazepam and paroxetine in patients with PD and comorbid depression will accelerate the onset of clinical response at both panic and depression symptoms PD with comorbid major depression is a more severe disorder than PD alone We will also examine whether the rapid and clinically meaningful benefits will be sustained until the end of the study despite tapering off clonazepam at the midpoint of the study If this study turns out to be the case combined SSRI-benzodiazepine treatment may become a standard initial therapeutic approach to PD and comorbid major depression
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-0136 | None | None | None |