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Completed

NCT Number: NCT00259883

Combination Of PAXIL Tablet And Benzodiazepines

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).

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Key information

Conditions

Mental Disorders Behavior Behavioral Symptoms Depression

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

paroxetine

Drug

1 or 2 tablets once a day

Primary outcomes

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

    Time frame: 8 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Dec 1, 2005
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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