Text Size

Major Depressive Disorder In The Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00093288
First received: October 5, 2004
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

This is a placebo-controlled study evaluating the effectiveness of medication in elderly subjects with Major Depressive Disorder (MDD).


Condition Intervention Phase
Depressive Disorder, Major
Major Depressive Disorder (MDD)
 Drug: bupropion XL
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible Dose Study to Evaluate the Efficacy, Safety and Tolerability of Extended-release Bupropion Hydrochloride (150mg-300mg Once Daily) in Elderly Subjects With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale

Secondary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale Clinical Global Impression Improvement Scale Clinical Global Impression Severity Scale Hamilton Anxiety Rating Scale

Estimated Enrollment: 364
Study Start Date: June 2004
Intervention Details:
    Drug: bupropion XL
    Other Name: bupropion XL
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary diagnosis of Major Depressive Disorder with DSM-IV criteria for their current episode for at least 8 weeks.

Exclusion Criteria:

  • Patient has current or past history of seizure disorder or brain injury.
  • Patient has a diagnosis of anorexia or bulimia within the past 12 months.
  • Patient has a past or current DMS-IV diagnosis of schizophrenia or any other psychotic disorder(s).
  • Patient has had a myocardial infarction within 1 year or a history of uncontrolled hypertension or unstable heart disease with 6 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093288

  Show 98 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00093288     History of Changes
Other Study ID Numbers: AK130940
Study First Received: October 5, 2004
Last Updated: August 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
MDD
bupropion
Depression

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

ClinicalTrials.gov processed this record on May 16, 2013