CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed
Drug / intervention
Paroxetine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00031317
NCT00031317Phase 4Completed

Combined Treatment With A Benzodiazepine (Clonazepam) And A Selective Serotonin Reuptake Inhibitor (Paroxetine) For Rapid Treatment Of Panic Disorder With Depression

National Institute of Mental Health (NIMH)·interventional·Posted Mar 1, 2002·Updated Mar 4, 2008

In Brief

A Phase 4 clinical trial evaluating Paroxetine and Clozapine for Panic Disorder. Completed, across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPanic Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 1, 2002
Enrollment StartFeb 1, 2002
Study CompletionJun 1, 2005
TodayJul 2, 2026
Posted 24.3 years ago

Interventions

Paroxetinedrug

Clozapinedrug