Study Of 323U66 SR In Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00135512
First received: August 24, 2005
Last updated: August 1, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Depressive Disorder
Drug: bupropion hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of 323U66 SR in Patients With Depression - Open-Label Study -

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • - 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 ]

Enrollment: 100
Study Start Date: December 2004
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: bupropion hydrochloride
    Study drug
    Other Name: bupropion hydrochloride
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135512

Locations
Japan
GSK Investigational Site
Fukuoka, Japan, 814-0180
GSK Investigational Site
Kanagawa, Japan, 228-0828
GSK Investigational Site
Kumamoto, Japan, 861-8002
GSK Investigational Site
Saitama, Japan, 332-0012
Spain
GSK Investigational Site
Unknown, Spain
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00135512     History of Changes
Other Study ID Numbers: AK1102364
Study First Received: August 24, 2005
Last Updated: August 1, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
MDD

Additional relevant MeSH terms:
Depression
Depressive Disorder
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Bupropion
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014