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

NCT00330616 | Completed Phase 2 Results

• 1 other identifier: AK1102369
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 9

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.

Conditions

Major Depressive Disorder (MDD)

Keywords

WELLBUTRIN; elderly; depression; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at 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).

  Baseline and Week 8

Secondary Outcomes (15)

• Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4

  Baseline and Week 4

• Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8

  Baseline and Week 8

• Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4

  Week 4

• Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8

  Week 8

• Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4

  Week 4

Interventions

323U66 SR DRUG

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• Major Depressive Disorder, Single Episode (296.2x) (excluding those with psychotic features)
• Major Depressive Disorder, Recurrent (296.3x). (excluding those with psychotic features)
• HAM-D (17 items) total score \>/=18.
• Age: \>/=65 years old (at the time of informed consent)
• Gender: Male or female.
• Inpatient or outpatient status: Either
• Informed consent: The subject himself/herself must give written informed consent.

You may not qualify if:

• Patients with predisposition to seizure (who currently have or have a past history of seizure, febrile convulsive seizure in infancy, cerebral tumour, cerebrovascular disorder or head injury, who have a family history of idiopathic seizure, patients with diabetes who have been treated with oral hypoglycaemics or insulin, or who use drugs lowering the threshold of seizure)
• Patients who currently have or have a past history of the following disorders:
• Anorexia nervosa (DSM-IV-TR 307.1)
• Bulimia nervosa (DSM-IV-TR 307.51)
• Patients with a history of manic episode
• Patients with a past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder
• Patients with a current DSM-IV-TR Axis II diagnosis (e.g., antisocial or borderline personality disorder)
• Patients starting psychotherapy (except for supportive psychotherapy not aimed at therapeutic efficacy and unlikely to affect efficacy evaluation) and standardized cognitive behaviour therapy within 12 weeks prior to the start of the treatment phase
• Patients with a diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria or with a diagnosis of substance dependence within 1 year prior to the start of the treatment phase
• Patients who have received electroconvulsive therapy within 24 weeks prior to the start of the treatment phase
• Patients who have taken MAO inhibitors (selegiline hydrochloride) within 2 weeks prior to the start of the treatment phase
• Patients who have taken another investigational drug within 12 weeks prior to the start of the pre-treatment phase
• Patients who have attempted suicide within 24 weeks prior to the start of the treatment phase, or patients for whom the score of the suicide-related item of HAM-D is \>/=3, or patients in whom the risk of suicide is judged to be high by the investigator (sub-investigator).
• Patients in whom the risk of homicide is judged to be high by the investigator (sub-investigator).
• Patients with a history of hypersensitivity to 323U66

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (9)

GSK Investigational Site

Fukuoka, 815-0041, Japan

Location

GSK Investigational Site

Fukushima, 961-0021, Japan

Location

GSK Investigational Site

Kumamoto, 861-8002, Japan

Location

GSK Investigational Site

Nagano, 395-0056, Japan

Location

GSK Investigational Site

Nagano, 399-8695, Japan

Location

GSK Investigational Site

Saitama, 332-0012, Japan

Location

GSK Investigational Site

Tokyo, 164-0012, Japan

Location

GSK Investigational Site

Tokyo, 170-0002, Japan

Location

GSK Investigational Site

Tokyo, 189-0012, Japan

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 26, 2006
• First Posted: May 29, 2006
• Study Start: May 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 4, 2015
• Results First Posted: March 20, 2009

Record last verified: 2009-06

Locations

JP (9)