Study Of 323U66 SR In Major Depressive Disorder

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00135512

First received: August 24, 2005

Last updated: January 22, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

August 24, 2005

Last Updated Date

January 22, 2009

Start Date ^ICMJE

December 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Change from baseline in the MADRS(Montgomery-Asberg Depression Rating Scale) total score. [ Time Frame: 8 Weeks ]

Original Primary Outcome Measures ^ICMJE

Change from baseline in the MADRS(Montgomery-Asberg Depression Rating Scale) total score

Change History

Complete list of historical versions of study NCT00135512 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

- Change from baseline in the HAM-D total score - Percentage of subjects who are CGI Global Improvement responders - Change from baseline in the SDS total score and the MEI-SF total score [ Time Frame: 8 Weeks ]

Original Secondary Outcome Measures ^ICMJE

- Change from baseline in the HAM-D total score - Percentage of subjects who are CGI Global Improvement responders - Change from baseline in the SDS total score and the MEI-SF total score

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study Of 323U66 SR In Major Depressive Disorder

Official Title ^ICMJE

Clinical Evaluation of 323U66 SR in Patients With Depression - Open-Label Study -

Brief Summary

This study was designed to evaluate the efficacy and safety in major depressive disorder patients.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Major Depressive Disorder (MDD)

Intervention ^ICMJE

Drug: bupropion hydrochloride

Other Name: bupropion hydrochloride

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion criteria:

Met DSM-IV-TR criteria for major depressive disorder for their current episode for at least 8 weeks prior to screening visit.
Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
Must have rating scores as outlined.

Exclusion criteria:

Current or past history of seizure disorder or brain injury.
Current or past history of anorexia or bulimia nervosa.
History of manic episode.
Past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder.
Diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria.
Pregnant, possibly pregnant or lactating.
Must not be suicidal.
Blood pressure of SBP>160mmHg, DBP>100mmHg.
History or complication of cancer or malignant tumour.

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00135512

Other Study ID Numbers ^ICMJE

AK1102364

Has Data Monitoring Committee

Not Provided

Responsible Party

Study Director, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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