Study Of Bupropion SR (323U66) In Patients With Major Depressive Disorder In Japan

Phase 2

Completed

• Conditions: Major Depressive Disorder (MDD)

• Registration Number: NCT00330616
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-26
• Study First Submitted QC: 2006-05-26
• Study First Posted: 2006-05-29
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Results First Submitted: 2008-11-26
• Results First Submitted QC: 2009-03-19
• Results First Posted: 2009-03-20
• Status Verified: 2009-06
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8	Baseline and Week 8	The Hamilton Rating Scale for Depression (HAM D) contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).

Secondary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4	Baseline and Week 4	The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).
Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8	Baseline and Week 8	The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).
Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4	Week 4	The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of \>/= 50% total score on the HAM D.
Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8	Week 8	The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of \>/= 50% total score on the HAM D.
Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4	Week 4	The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of \</= 7.
Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8	Week 8	The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of \</= 7.
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4	Baseline and Week 4	The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8	Baseline and Week 8	The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4	Baseline and Week 4	The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 53 (severely ill).
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8	Baseline and Week 8	The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).
Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8	Week 4 and Week 8	The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).
Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8	Week 4 and Week 8	The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I.
Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8	Baseline, Weeks 1, 2, 3, 4, 8	The CGI-S assesses the investigator's impression of the severity of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Adverse Events (>=5% Incidence)	Baseline through Week 8
Serious Adverse Events	Baseline through Week 8

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Tokyo, Japan