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Evaluation of Clonazepam and Paroxetine for Panic Disorder With Depression

NCT00031317 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2008-03-04

No results posted yet for this study

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.

Conditions

  • Panic Disorder

Interventions

DRUG

Paroxetine

DRUG

Clozapine

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Completion
2005-06-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00031317 on ClinicalTrials.gov