Combination Of PAXIL Tablet And Benzodiazepines

Phase 4

Completed

• Conditions: Mental Disorders
• Interventions: Drug: paroxetine

• Registration Number: NCT00259883
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study was designed to assess the efficacy and safety of combination therapy of PAXIL and benzodiazepine anxiolytics. PAXIL Tablet will be administered to patients with depression or depressive episodes who have received Benzodiazepines for at least 4 weeks, and changes in the symptoms of depression will be evaluated by use of the rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-11-30
• Study First Submitted QC: 2005-11-30
• Study First Posted: 2005-12-01
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
paroxetine	paroxetine	paroxetine 20 to 40mg/day

Primary Outcome Measures

Name	Time	Method
The rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D)	8 weeks

Secondary Outcome Measures

Name	Time	Method
The rate and extent of decrease in each item of HAM-D. The rate and extent of decrease of SRQ-D. Percentage of subjects who started tapering Benzodiazepine dose. Success rate in Benzodiazepine tapering Extent increase of SF-8. CGI responder rate.	8 weeks

Trial Locations

Locations (1)

GSK Investigational Site