Combination Of PAXIL Tablet And Benzodiazepines

GlaxoSmithKline150 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Mental Disorders

Interventions

paroxetineDRUG

1 or 2 tablets once a day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion criteria: * Patients with depression or depressive episodes who are diagnosed to have major depressive disorders according to the DSM-IV criteria. * Patients with 14 or higher points in total scores for Items No.1 - 17 on HAM-D. * Patients who have continuously received Benzodiazepine anxiolytics. Exclusion criteria: * Patients with a strong suicide tendency.

Locations (1)

GSK Investigational Site

Outcomes

Primary Outcomes

The rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D)

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 8 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.