NCT00135512

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2004

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2007

Completed
11.7 years until next milestone

Results Posted

Study results publicly available

February 1, 2019

Completed
Last Updated

February 1, 2019

Status Verified

August 1, 2018

Enrollment Period

2.5 years

First QC Date

August 24, 2005

Results QC Date

June 22, 2017

Last Update Submit

August 30, 2018

Conditions

Depressive Disorder

Keywords

MDD

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 in Observed Cases

    The MADRS is a semi-structured interview rating scale for depression that assesses 10 symptoms. The scale is composed of 10 questions (1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts) with a fixed 7 point scale (0, no depression; 60, severely depressed). Total score ranges from 0-60. A higher score indicates more depressive symptoms. MADRS Response was defined as a reduction in MADRS score from Baseline. Change from Baseline in the total score was calculated as the value at Week 8 minus the value at Baseline. Baseline was defined as value at Week 0.

    Baseline (Week 0) and Week 8

Secondary Outcomes (6)

  • Change From Baseline in the MADRS Total Score at Week 52 in Observed Cases

    Baseline (Week 0) and Week 52

  • Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Weeks 8 and 52 in Observed Cases

    Baseline (Week 0) and Week 8, 52

  • Percentage of Participants Who Were Clinical Global Impression Global Improvement (CGI-I) Responders at Weeks 8 and 52 in Observed Cases

    Week 8, 52

  • Change From Baseline in CGI Severity of Illness (CGI-SI) at Weeks 8 and 52 in Observed Cases

    Baseline (Week 0) and Week 8, 52

  • Change From Baseline in the Sheehan Disability Scale (SDISS) Total Score at Weeks 8 and 52 in Observed Cases

    Baseline (Week 0) and Week 8, 52

  • +1 more secondary outcomes

Interventions

bupropion hydrochlorideDRUG

Study drug

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

GSK Investigational Site

Fukuoka, 814-0180, Japan

Location

GSK Investigational Site

Hyōgo, 651-1145, Japan

Location

GSK Investigational Site

Kanagawa, 228-0828, Japan

Location

GSK Investigational Site

Kumamoto, 861-8002, Japan

Location

GSK Investigational Site

Saitama, 332-0012, Japan

Location

GSK Investigational Site

Tokyo, 160-0023, Japan

Location

GSK Investigational Site

Location

MeSH Terms

Conditions

Depressive Disorder

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 26, 2005

Study Start

December 1, 2004

Primary Completion

May 28, 2007

Study Completion

May 28, 2007

Last Updated

February 1, 2019

Results First Posted

February 1, 2019

Record last verified: 2018-08

Locations

JP(6)