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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00330616 |
This is a study to obtain clinical experience of 323U66 SR for elderly patients with depression in repeat-dose of 323U66 SR up to 300mg/day, and to conduct exploratory investigation on safety, efficacy and pharmacokinetics profile in elderly patients with depression.
Condition | Intervention | Phase |
---|---|---|
Major Depressive Disorder (MDD) |
Drug: 323U66 SR |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Safety/Efficacy Study |
Official Title: | Clinical Evaluation of 323U66 SR in Patients With Depression - Investigation in Elderly Patients With Depression - |
Estimated Enrollment: | 30 |
Study Start Date: | May 2006 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Target disease: Patients diagnosed as having the following primary disease and current major depressive episode for at least 8 weeks on the basis of DSM-IV-TR criteria.
Exclusion criteria:
Patients who currently have or have a past history of the following disorders:
The index of seriousness is Grade 3 of "Criteria for classification of seriousness of adverse drug reactions to pharmaceutical products, etc." (PAB/PSD No.80 in 1992).
Japan | |
GSK Investigational Site | |
Tokyo, Japan, 164-0012 | |
GSK Investigational Site | |
Tokyo, Japan, 170-0002 | |
GSK Investigational Site | |
Saitama, Japan, 332-0012 | |
GSK Investigational Site | |
Fukuoka, Japan, 815-0041 | |
GSK Investigational Site | |
Kumamoto, Japan, 861-8002 | |
GSK Investigational Site | |
Nagano, Japan, 395-0056 | |
GSK Investigational Site | |
Tokyo, Japan, 189-0012 | |
GSK Investigational Site | |
Fukushima, Japan, 961-0021 | |
GSK Investigational Site | |
Nagano, Japan, 399-8695 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | AK1102369 |
Study First Received: | May 26, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00330616 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
WELLBUTRIN elderly depression Pharmacokinetics |
Depression Mental Disorders Bupropion Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
Pathologic Processes Disease |