NCT00259883

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

November 30, 2005

Last Update Submit

January 16, 2017

Conditions

Mental Disorders

Keywords

depressive episodesparoxetinePAXILdepressionbenzodiazepinecombination

Outcome Measures

Primary Outcomes (1)

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

    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.

    8 weeks

Study Arms (1)

paroxetine

EXPERIMENTAL

paroxetine 20 to 40mg/day

Drug: paroxetine

Interventions

paroxetineDRUG

1 or 2 tablets once a day

paroxetine

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with a strong suicide tendency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Location

MeSH Terms

Conditions

Mental DisordersDepression

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 1, 2005

Study Start

June 1, 2005

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

January 18, 2017

Record last verified: 2017-01