Combination Of PAXIL Tablet And Benzodiazepines

Condition(s) targeted: Depression

Intervention: paroxetine (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, 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).

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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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.

Criteria:

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.

GSK Clinical Trials Call Center, Chiba 270, Japan

GSK clinical trials call center, Tokyo 185, Japan

GSK clinical trials call center, Tokyo 184, Japan

GSK clinical trials call center, Tokyo 143, Japan

GSK clinical trials call center, Tokyo 136, Japan

GSK clinical trials call center, Tokyo 104, Japan

GSK clinical trials call center, Chiba 260, Japan

GSK clinical trials call center, Hyogo 662, Japan

GSK clinical trials call center, Osaka 559, Japan

GSK clinical trials call center, Saitama 336, Japan

GSK clinical trials call center, Tokyo 205, Japan

GSK clinical trials call center, Tokyo 150, Japan

GSK Clinical Trials Call Center, Tokyo 154, Japan

GSK clinical trials call center, Chiba 278, Japan

GSK clinical trials call center, Tokyo 116, Japan

GSK clinical trials call center, Tokyo 101, Japan

GSK clinical trials call center, Tokyo 106, Japan

GSK clinical trials call center, Tokyo 121, Japan

GSK clinical trials call center, Tokyo 141, Japan

GSK clinical trials call center, Kanagawa 220, Japan

GSK clinical trials call center, Tokyo 139, Japan

GSK clinical trials call center, Kanagawa 228, Japan

GSK clinical trials call center, Kanagawa 230, Japan

GSK clinical trials call center, Kanagawa 226, Japan

GSK clinical trials call center, Saitama 341, Japan

GSK clinical trials call center, Shizuoka 410, Japan

GSK clinical trials call center, Chiba 272, Japan

GSK clinical trials call center, Osaka 530, Japan

GSK clinical trials call center, Osaka 536, Japan

GSK clinical trials call center, Osaka 574, Japan

GSK clinical trials call center, Fukushima 964, Japan

GSK clinical trials call center, Fukushima 960, Japan

GSK clinical trials call center, Fukushima 963, Japan

GSK clinical trials call center, Tokyo 158, Japan

GSK clinical trials call center, Tokyo 180, Japan

Starting date: May 2005
Last updated: April 25, 2006