Combination Of PAXIL Tablet And Benzodiazepines | NCT00259883

Studies
Combination Of PAXIL Tablet And Benzodiazepines

NCT00259883

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Jan 18, 2017Estimated

Enrollment

150Actual

Phase

Phase 4

Conditions

Mental Disorders

Interventions

paroxetine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Feb 2006Actual

Completion Date

Feb 2006Actual

First Submitted Date

Nov 30, 2005

First Submission Date that Met QC Criteria

Nov 30, 2005

First Posted Date

Dec 1, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2017

Last Update Posted Date

Jan 18, 2017Estimated

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
paroxetine	Experimental	paroxetine 20 to 40mg/day	Drug: paroxetine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
paroxetine	Drug	1 or 2 tablets once a day	paroxetine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D)		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Type	Date	Date Unknown
Release	Jun 29, 2017
Unrelease		Yes
Release	Aug 3, 2017
Reset	Feb 15, 2018
Release	Mar 7, 2018
Unrelease	Aug 15, 2018
Release	Aug 27, 2018
Unrelease	Aug 30, 2018
Release	Aug 30, 2018
Reset	Jan 31, 2019

Submission Tracking

Estimated Results First Submitted Date

Jun 29, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 29, 2017		Yes
Aug 3, 2017

Condition Browse Module

MeSH Terms

ID	Term
D001523	Mental Disorders
D003863	Depression

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017374	Paroxetine

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided