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Combination Of PAXIL Tablet And Benzodiazepines

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mental Disorders

Intervention: paroxetine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline


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).

Clinical Details

Official title: Post-marketing Clinical Study on PAXIL Tablet in Patients With Depression or Depressive Mood - A Study on Combination of PAXIL Tablet and Benzodiazepines

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome: 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.


Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.


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 and Contacts

Additional Information

Starting date: June 2005
Last updated: April 11, 2013

Page last updated: August 23, 2015

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