Trial record 2 of 3 for:
bupropion | Russia
Major Depressive Disorder In The Elderly
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00093288 |
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Recruitment Status :
Completed
First Posted : October 7, 2004
Last Update Posted : September 2, 2013
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
This is a placebo-controlled study evaluating the effectiveness of medication in elderly subjects with Major Depressive Disorder (MDD).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Depressive Disorder, Major | Drug: bupropion XL | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 364 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| 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 |
| Study Start Date : | June 2004 |
| Actual Primary Completion Date : | October 2005 |
| Actual Study Completion Date : | October 2005 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Depression
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
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093288
Locations
| Australia, Queensland | |
| GSK Investigational Site | |
| Caboolture, Queensland, Australia, 4510 | |
| GSK Investigational Site | |
| Everton Park, Queensland, Australia, 4053 | |
| GSK Investigational Site | |
| New Farm, Queensland, Australia, 4005 | |
| Australia, Victoria | |
| GSK Investigational Site | |
| St. Albans, Victoria, Australia, 3021 | |
| Belgium | |
| GSK Investigational Site | |
| Liège, Belgium, 4000 | |
| GSK Investigational Site | |
| Mont-Godinne, Belgium, 5530 | |
| GSK Investigational Site | |
| Montignies-sur-Sambre, Belgium, 6061 | |
| Finland | |
| GSK Investigational Site | |
| Mikkeli, Finland, 50100 | |
| Netherlands | |
| GSK Investigational Site | |
| Amersfoort, Netherlands, 3818 ES | |
| GSK Investigational Site | |
| Grubbenvorst, Netherlands, 5971 BB | |
| GSK Investigational Site | |
| Hilversum, Netherlands, 1211 PA | |
| GSK Investigational Site | |
| Hoogvliet, Netherlands, 3192 JN | |
| GSK Investigational Site | |
| Wildervank, Netherlands, 9648 BE | |
| Norway | |
| GSK Investigational Site | |
| Oslo, Norway, 0407 | |
| Russian Federation | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 115522 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 119992 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00093288 History of Changes |
| Other Study ID Numbers: |
AK130940 |
| First Posted: | October 7, 2004 Key Record Dates |
| Last Update Posted: | September 2, 2013 |
| Last Verified: | August 2013 |
Keywords provided by GlaxoSmithKline:
|
MDD bupropion Depression |
Additional relevant MeSH terms:
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Bupropion Disease Depressive Disorder Depression Depressive Disorder, Major Pathologic Processes Mood Disorders Mental Disorders Behavioral Symptoms Antidepressive Agents, Second-Generation Antidepressive Agents |
Psychotropic Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |