Study In Patients With Depression Not Responding to Selective Serotonin Re-uptake Inhibitors

NCT00296517 | Completed Phase 3 Results

• 1 other identifier: AK1102365
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 62

Brief Summary

This study is designed to evaluate the efficacy and safety in depressive patients who did not respond sufficiently to selective serotonin re-uptake inhibitors (SSRI).

Conditions

Depressive Disorder

Keywords

depression; double-blind; placebo-controlled; bupropion hydrochloride; SSRI; comparative study; non-responder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score

  The Hamilton Rating Scale for Depression 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 52 (severely ill).

  Baseline and Week 12

Secondary Outcomes (11)

• Hamilton Depression Scale (HAM-D 17 Items) Total Score

  Week 8 and Week 12

• Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12

  Baseline to Week 8 and Week 12

• Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12.

  Baseline to Week 8 and Week 12

• Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12

  Baseline to Week 8 and Week 12

• Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12

  Baseline to Week 8 and Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period.

Drug: Placebo

Bupropion SR

EXPERIMENTAL

Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg.

Drug: 323U66 (Bupropion Hydrochloride Sustained Release)

Interventions

323U66 (Bupropion Hydrochloride Sustained Release) DRUG

Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg.

Bupropion SR

Placebo DRUG

Subjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[At the start of the pretreatment phase\]
• Target disease: Patients diagnosed as having the following primary disease on the basis of DSM-IV-TR criteria.
• Major Depressive Disorder, Single Episode (296.2x) (excluding with psychotic features)
• Major Depressive Disorder, Recurrent (296.3x) (excluding with psychotic features)
• HAM-D (17 items) total score is \>=16.
• Patients who have been treated with marketed paroxetine (Paxil®) at 20mg/day to 40mg/day for 4 weeks and more at the start of the pretreatment phase.
• Age: \>=18 years old (at the time of informed consent) , \<65 years old (at the start of treatment phase )
• Gender: Male or female.
• Inpatients or outpatients: Either
• Informed consent: The subject himself/herself must give written informed consent. However, if the subject is under 20 at the time of giving consent, both the subject himself/herself and his/her legally acceptable representative must give written informed consent.
• \[At the end of the pretreatment phase\]
• HAM-D (17 items) total score is ≥14.
• Percentage of change from the start of the pretreatment phase in the HAM-D (17 items) total score is \<50%
• \[At the start of the treatment phase\]
• HAM-D (17 items) total score is ≥14.

You may not qualify if:

• \[At the start of the pre-treatment phase\]
• Patients with a complication of glaucoma
• Patients concomitantly using a drug increasing the risk of bleeding and patients with bleeding tendency or predisposition to bleeding
• 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 formal cognitive behaviour therapy within 5 weeks prior to the start of the pre-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 pre-treatment phase
• Patients who have received electroconvulsive therapy within 17 weeks prior to the start of the pre-treatment phase
• Patients who have taken MAO inhibitors (selegiline hydrochloride) within 2 weeks prior to the start of the pre-treatment phase
• Patients who have taken another investigational drug within 12 weeks prior to the start of the pre-treatment phase

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (62)

GSK Investigational Site

Aichi, 462-0831, Japan

Location

GSK Investigational Site

Aichi, 470-1141, Japan

Location

GSK Investigational Site

Aichi, 475-0074, Japan

Location

GSK Investigational Site

Chiba, 270-1613, Japan

Location

GSK Investigational Site

Fukuoka, 802-0006, Japan

Location

GSK Investigational Site

Fukuoka, 810-0001, Japan

Location

GSK Investigational Site

Fukuoka, 814-0180, Japan

Location

GSK Investigational Site

Fukuoka, 816-0801, Japan

Location

GSK Investigational Site

Fukuoka, 816-0864, Japan

Location

GSK Investigational Site

Fukushima, 960-0102, Japan

Location

GSK Investigational Site

Fukushima, 961-0021, Japan

Location

GSK Investigational Site

Fukushima, 963-0207, Japan

Location

GSK Investigational Site

Hokkaido, 002-8029, Japan

Location

GSK Investigational Site

Hokkaido, 004-0052, Japan

Location

GSK Investigational Site

Hokkaido, 004-0841, Japan

Location

GSK Investigational Site

Hokkaido, 047-0155, Japan

Location

GSK Investigational Site

Hokkaido, 060-0042, Japan

Location

GSK Investigational Site

Hokkaido, 060-0061, Japan

Location

GSK Investigational Site

Hokkaido, 062-0922, Japan

Location

GSK Investigational Site

Hokkaido, 063-0061, Japan

Location

GSK Investigational Site

Hokkaido, 063-0804, Japan

Location

GSK Investigational Site

Hokkaido, 080-0014, Japan

Location

GSK Investigational Site

Hyōgo, 651-0092, Japan

Location

GSK Investigational Site

Hyōgo, 651-0097, Japan

Location

GSK Investigational Site

Hyōgo, 653-0841, Japan

Location

GSK Investigational Site

Hyōgo, 657-0846, Japan

Location

GSK Investigational Site

Ibaraki, 300-0812, Japan

Location

GSK Investigational Site

Ibaraki, 311-3193, Japan

Location

GSK Investigational Site

Ishikawa, 920-0939, Japan

Location

GSK Investigational Site

Kagawa, 761-0793, Japan

Location

GSK Investigational Site

Kanagawa, 213-0001, Japan

Location

GSK Investigational Site

Kanagawa, 223-0052, Japan

Location

GSK Investigational Site

Kanagawa, 225-0011, Japan

Location

GSK Investigational Site

Kanagawa, 231-0023, Japan

Location

GSK Investigational Site

Kanagawa, 238-0042, Japan

Location

GSK Investigational Site

Kumamoto, 861-8002, Japan

Location

GSK Investigational Site

Nagano, 390-8510, Japan

Location

GSK Investigational Site

Nara, 639-0225, Japan

Location

GSK Investigational Site

Okayama, 700-0941, Japan

Location

GSK Investigational Site

Osaka, 530-0026, Japan

Location

GSK Investigational Site

Osaka, 571-0048, Japan

Location

GSK Investigational Site

Osaka, 576-0054, Japan

Location

GSK Investigational Site

Osaka, 582-0025, Japan

Location

GSK Investigational Site

Osaka, 589-0011, Japan

Location

GSK Investigational Site

Osaka, 590-0018, Japan

Location

GSK Investigational Site

Tokyo, 107-0052, Japan

Location

GSK Investigational Site

Tokyo, 108-0072, Japan

Location

GSK Investigational Site

Tokyo, 110-0005, Japan

Location

GSK Investigational Site

Tokyo, 114-0014, Japan

Location

GSK Investigational Site

Tokyo, 120-0033, Japan

Location

GSK Investigational Site

Tokyo, 141-0032, Japan

Location

GSK Investigational Site

Tokyo, 152-0012, Japan

Location

GSK Investigational Site

Tokyo, 154-0003, Japan

Location

GSK Investigational Site

Tokyo, 154-0004, Japan

Location

GSK Investigational Site

Tokyo, 160-0023, Japan

Location

GSK Investigational Site

Tokyo, 170-0002, Japan

Location

GSK Investigational Site

Tokyo, 170-0005, Japan

Location

GSK Investigational Site

Tokyo, 178-0063, Japan

Location

GSK Investigational Site

Tokyo, 194-0022, Japan

Location

GSK Investigational Site

Tokyo, 204-0022, Japan

Location

GSK Investigational Site

Tottori, 682-0023, Japan

Location

GSK Investigational Site

Tottori, 683-8504, Japan

Location

MeSH Terms

Conditions

Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

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

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 27, 2006
• Study Start: January 19, 2006
• Primary Completion: March 28, 2008
• Study Completion: March 28, 2008
• Last Updated: December 4, 2019
• Results First Posted: July 16, 2009

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

JP (62)