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A Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD)

Primary Purpose

Depressive Disorder, Major

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

323U66 SR 150 mg tablet

323U66 SR 150 mg placebo tablet

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Bupropion, 323U66 Sustained Release (SR), MDD (Major Depressive Disorder), IVRS HAM-D, IDS-SR, MADRS

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

[At the start time of the run-in phase]

Subject must have a primary diagnosis of major depressive disorder as classified by the DSM-IV-TR criteria as below (however, to exclude those accompanied by comorbid psychiatric disorders), and be showing currently a symptom of depression or depressive status: Major depressive disorder, single episode (296.2x); Major depressive disorder, recurrent (296.3x).
Subject must have a total score of >=20 on the IVRS HAM-D (17 items).
Subject must have a total score of >=25 on the IDS-SR.
Subject must have a score of >=1 on 4 out 5 items on the 5-item subscale of the IDS-SR (Item 19, 20, 21, 22 and 30), and a total score of >=7 on the 5-item subscale of the IDS-SR.
Subject must have a CGI-SI score of >=4 (i.e., Moderately ill or much worse).
Subject must have the current depressive episode's duration of >=8 weeks but <24 months.
Subject is outpatient.
Subject must show QTc <450 millisecond (msec) or <480msec with Bundle Branch Block - values based on either single ECG values or triplicate ECG averaged QTc values obtained over a brief recording period.
Subject must show a value less than twice of the upper limit of normal value range of AST (GOT) and ALT (GPT), and a value <=1.5 times of the upper limit of normal value range of both Al-P and total bilirubin (however, subject who shows >35% of direct bilirubin with a value >=1.5 times of the upper limit of normal range of total bilirubin regards eligible).
Subject must read and write at a level sufficient to provide written informed consent prior to study participation and complete study-related materials. If subject is <20 years of age at the time of giving consent, both the subject himself / herself and his / her proxy consenter must give written informed consent.

[At the start time of the treatment phase]

Subject must have a total score of >=20 of the IVRS-based HAM-D (17 items).
Subject whose IVRS HAM-D (17 items) total score has not been increased or decreased by >25% during the run-in phase.
Subject must have a total score of >=25 on the IDS-SR.
Subject must have a score of >=1 on 4 out 5 items on the 5-item subscale of the IDS-SR (Item 19, 20, 21, 22 and 30), and a total score of >=7 on the 5-item subscale of the IDS-SR.
Subject must have a CGI-SI score of >=4 (i.e., Moderately ill or much worse).

Exclusion Criteria:

[At the start time of Run-in phase (Visit 1)]

Subject has predispositions to seizure: who currently has or has a past history of seizure or seizure disorder, more than a single febrile seizure in infancy, cerebral tumour, or head / brain injury (traumatic); who has a family history of idiopathic seizure; who is diabetic patient with treating by oral hypoglycaemics or insulin; who uses drugs lowering the threshold of seizure.
Subject has a history or current diagnosis of anorexia nervosa (DSM-IV-TR 307.1) or bulimia (DSM-IV-TR 307.51).
Subject has a primary DSM-IV diagnosis of, or received treatment for, panic disorder, obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD), or acute stress disorder within 12 months before the start time of Run-in phase.
Subject has a DSM-IV diagnosis of schizophrenia, or other psychotic disorder(s) including bipolar disorder.
Subject has a history of or currently has manic episode(s).
Subject has any other DSM-IV axis II diagnosis that would suggest non-responsiveness to pharmacotherapy or non-compliance with the protocol (e.g., antisocial, borderline disorder or narcissistic personality disorder).
Subject starting psychotherapy (except for supportive psychotherapy not aimed at therapeutic efficacy and unlikely to affect efficacy evaluation) or a cognitive behaviour therapy within 12 weeks before start time of the run-in phase.
Subject received electroconvulsive therapy (ECT) within 24 weeks before start time of the run-in phase.
Subject took MAO inhibitors (selegiline hydrochloride) within 2 weeks before start time of the run-in phase.
Subject who has undergone treatment with a depot neuroleptic in the past.
Subject has systolic blood pressure of >=160 mmHg or diastolic pressure of >=100 mmHg.
Subject 1) is possibly pregnant, 2) is pregnant, lactating, or 3) does not agree to use contraceptive method(s) specified in the protocol to avoid pregnancy during the study (females only). Or subject wants to become pregnant during the study (females only).
Subject has a history of alcohol / substance abuse or dependence within 12 months before start time of the run-in phase and/or has a positive result in a urine test for illicit drug use at start time of the run-in phase.
Subject, who in the opinion of the investigator (or sub-investigator), poses a current serious suicidal risk or has made a suicide attempt within the past 6 months.
Subject took another investigational product for the NDA filing or for the post manufacturing / marketing approval study within 12 weeks before start time of the run-in phase.
Subject is currently participating in another clinical study in which the subject is or will be exposed to an investigational or non-investigational drug or medical device.
Subject has a history of non-responsiveness to 323U66 SR treatment in the investigational clinical trial for major depressive disorder.
Subject has a history of withdrawal from the investigational clinical trial of 323U66 SR for major depressive disorder due to any adverse event(s).
Subject has a history of hypersensitivity to 323U66 (bupropion).
Subject, who in the opinion of the investigator (or sub-investigator), has a risk of homicide.
Subject has serious cerebral disease(s).
Subject has serious physical symptom(s) (i.e., cardiac / hepatic / renal / hematopoietic disorder(s)).
Subject whose major depressive disorder is due to direct physiological effects of a general medical condition(s) (e.g. hypothyroidism, Parkinson's disease, chronic pain).
Subject is complicated by chronic hepatitis B or C being positive in test of hepatitis B surface antigen (HbsAg) or hepatitis C antibody.
Subject who is in the process of quitting smoking with nicotine formulation.
Subject has previously failed adequate (in terms of dose and duration of therapy) courses of pharmacotherapy with at least two different classes of antidepressants.
Subjects undergoing abrupt discontinuation of alcohol or sedatives.
Subject is inappropriate for participating in the study that is felt by the investigator (or sub-investigator).

[At the start time of the treatment phase]

Subject, who in the opinion of the investigator (or sub-investigator), poses a current serious suicidal risk.
Subject is inappropriate for participating in the study that is felt by the investigator (or sub-investigator).

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

323U66 SR 150 mg cohort

323U66 SR 300 mg cohort

Placebo cohort

Arm Description

323U66 SR 150 mg tablet is orally administered once in the morning and 323U66 SR 150 mg placebo tablet is orally administered once in the evening throughout the treatment phase.

323U66 SR 150 mg tablet is orally administered once in the morning and 323U66 SR 150 mg placebo tablet is orally administered once in the evening during the first week of the treatment phase. At the second week, 323U66 SR 300mg cohort is up-titrated to a daily dose of 323U66 SR 300 mg, administered as 323U66 SR 150 mg tablet twice daily in the morning and in the evening, and the same daily dose is maintained to administer until the end of the treatment phase.

323U66 SR placebo tablet is orally administered twice daily throughout the treatment phase.

Outcomes

Primary Outcome Measures

Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8/Withdrawal

The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 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. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Change from Baseline in the total score was calculated as the value at Week 8/Withdrawal minus the value at Baseline. The least squared means were estimated based on the Analysis of Covariance (ANCOVA) model including Baseline MADRS score and region as covariates.

Secondary Outcome Measures

Change From Baseline in the MADRS Total Score at Weeks 1, 2, 4, and 6

The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 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. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Change from Baseline in the total score was calculated as the value at Week 1, 2, 4 and 6 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline MADRS score and region as covariates.

Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8

The MADRS scale measures the depression level of a participant using the following 10 items: 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. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). Scores for MADRS items 1, 2, 6, 7, and 8 were evaluated for this endpoint. Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline MADRS score of each item and region as covariates.

Number of MADRS Responders at Week 8

The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 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. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. A MADRS responder is defined as a participant with a >=50% reduction from Baseline in the MADRS total score at Week 8.

Number of MADRS Remitters at Week 8

The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 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. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. A MADRS remitter is defined as a participant with a MADRS total score <=11 at Week 8.

Number of Clinical Global Impression-Global Improvement (CGI-GI) Responders at Week 8

A CGI-GI assessment was performed at Week 8 (or withdrawal) in comparison with severity in depression observed at Baseline (Week 0; no actual assessment was performed at Baseline [the comparison was subjective]), by using scores from 0 to 7: 0, Not assessed; 1, Very much improved; 2, Much improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; 7, Very much worse. A CGI-GI responder is defined as a participant with a CGI-GI score of very much improved or much improved at Week 8.

Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 4, 6, and 8

A CGI-SI assessment was performed in terms of severity in depression, by using scores from 0 to 7: 0, Not assessed; 1, Normal, not at all ill; 2, Borderline mentally ill; 3, Mildly ill; 4, Moderately ill; 5, Markedly ill; 6, Severely ill; 7, Among the most extremely ill participants. Change from Baseline in the CGI-SI score was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline CGI-SI score and region as covariates.

Change From Baseline in the Inventory of Depressive Symptomatology-Self Report (IDS-SR) Total Score at Weeks 1, 2, 4, 6, and 8

The IDS-SR is a 30-item scale used to evaluate the severity and changes in depressive symptoms. Each item was scored from 0 (no symptoms) to 3 (greatest symptom severity). The maximum total score is 84 (0: no symptoms; 84: greatest symptom severity), as participants were asked to answer either item 11 (decreased appetite) or item 12 (increased appetite) (not both) and either item 13 (decreased weight) or item 14 (increased weight) (not both). Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline IDS-SR score and region as covariates.

Change From Baseline in the IDS-SR Subscores for Energy, Pleasure, and Interest at Weeks 1, 2, 4, 6, and 8

The IDS-SR is a 30-item scale used to evaluate the severity and changes in depressive symptoms. Each item was scored from 0 (no symptoms) to 3 (greatest symptom severity). Only five items (item 19: general interest; item 20: energy level; item 21: capacity for pleasure or enjoyment, excluding sex; item 22: interest in sex; item 30: leaden paralysis/physical energy) were evaluated for this endpoint, as a subset of the total score. The lowest possible total score and subset total score of IDS-SR are 0 and 0, and the highest possible total score and subset total score of IDS-SR are 84 and 15, respectively. Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline IDS-SR subscore and region as covariates.

Full Information

NCT ID

NCT01138007

First Posted

June 3, 2010

Last Updated

June 18, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01138007

Brief Title

A Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD)

Official Title

Study AK1113351, a Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD) - a Multi-center, Placebo-controlled, Randomized, Double-blind, Parallel-comparison Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

June 17, 2010 (undefined)

Primary Completion Date

August 1, 2012 (Actual)

Study Completion Date

August 7, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a multi-center, placebo-controlled, randomized, double-blind, parallel-comparison study to confirm the efficacy of 323U66 Sustained Release (SR) orally administered to patients with MDD (Major Depressive Disorder) at doses level of 150 mg/day and 300 mg/day for 8 weeks based on the decrease in MADRS (Montgomery-Asberg Depression Rating Scale) total score, and to evaluate the safety based on adverse events, clinical laboratory tests and vital signs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Major

Keywords

Bupropion, 323U66 Sustained Release (SR), MDD (Major Depressive Disorder), IVRS HAM-D, IDS-SR, MADRS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

572 (Actual)

8. Arms, Groups, and Interventions

Arm Title

323U66 SR 150 mg cohort

Arm Type

Experimental

Arm Description

323U66 SR 150 mg tablet is orally administered once in the morning and 323U66 SR 150 mg placebo tablet is orally administered once in the evening throughout the treatment phase.

Arm Title

323U66 SR 300 mg cohort

Arm Type

Experimental

Arm Description

Arm Title

Placebo cohort

Arm Type

Placebo Comparator

Arm Description

323U66 SR placebo tablet is orally administered twice daily throughout the treatment phase.

Intervention Type

Drug

Intervention Name(s)

323U66 SR 150 mg tablet

Intervention Description

323U66 SR 150 mg tablet is orally administered once in the morning and/or once in the evening during the teatment phase.

Intervention Type

Drug

Intervention Name(s)

323U66 SR 150 mg placebo tablet

Intervention Description

323U66 SR 150 mg placebo tablet is orally administered once in the evening and/or once in the morning during the teatment phase.

Primary Outcome Measure Information:

Title

Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8/Withdrawal

Description

Time Frame

Baseline and Week 8/Withdrawal

Secondary Outcome Measure Information:

Title

Change From Baseline in the MADRS Total Score at Weeks 1, 2, 4, and 6

Description

The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 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. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Change from Baseline in the total score was calculated as the value at Week 1, 2, 4 and 6 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline MADRS score and region as covariates.

Time Frame

Baseline; Weeks 1, 2, 4, and 6

Title

Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8

Description

Time Frame

Baseline; Week 1, 2, 4, 6, and 8

Title

Number of MADRS Responders at Week 8

Description

The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 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. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. A MADRS responder is defined as a participant with a >=50% reduction from Baseline in the MADRS total score at Week 8.

Time Frame

Baseline and Week 8

Title

Number of MADRS Remitters at Week 8

Description

The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 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. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. A MADRS remitter is defined as a participant with a MADRS total score <=11 at Week 8.

Time Frame

Week 8

Title

Number of Clinical Global Impression-Global Improvement (CGI-GI) Responders at Week 8

Description

Time Frame

Week 8

Title

Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 4, 6, and 8

Description

Time Frame

Baseline; Weeks 1, 2, 4, 6, and 8

Title

Change From Baseline in the Inventory of Depressive Symptomatology-Self Report (IDS-SR) Total Score at Weeks 1, 2, 4, 6, and 8

Description

Time Frame

Baseline; Weeks 1, 2, 4, 6, and 8

Title

Change From Baseline in the IDS-SR Subscores for Energy, Pleasure, and Interest at Weeks 1, 2, 4, 6, and 8

Description

Time Frame

Baseline; Weeks 1, 2, 4, 6, and 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: [At the start time of the run-in phase] Subject must have a primary diagnosis of major depressive disorder as classified by the DSM-IV-TR criteria as below (however, to exclude those accompanied by comorbid psychiatric disorders), and be showing currently a symptom of depression or depressive status: Major depressive disorder, single episode (296.2x); Major depressive disorder, recurrent (296.3x). Subject must have a total score of >=20 on the IVRS HAM-D (17 items). Subject must have a total score of >=25 on the IDS-SR. Subject must have a score of >=1 on 4 out 5 items on the 5-item subscale of the IDS-SR (Item 19, 20, 21, 22 and 30), and a total score of >=7 on the 5-item subscale of the IDS-SR. Subject must have a CGI-SI score of >=4 (i.e., Moderately ill or much worse). Subject must have the current depressive episode's duration of >=8 weeks but <24 months. Subject is outpatient. Subject must show QTc <450 millisecond (msec) or <480msec with Bundle Branch Block - values based on either single ECG values or triplicate ECG averaged QTc values obtained over a brief recording period. Subject must show a value less than twice of the upper limit of normal value range of AST (GOT) and ALT (GPT), and a value <=1.5 times of the upper limit of normal value range of both Al-P and total bilirubin (however, subject who shows >35% of direct bilirubin with a value >=1.5 times of the upper limit of normal range of total bilirubin regards eligible). Subject must read and write at a level sufficient to provide written informed consent prior to study participation and complete study-related materials. If subject is <20 years of age at the time of giving consent, both the subject himself / herself and his / her proxy consenter must give written informed consent. [At the start time of the treatment phase] Subject must have a total score of >=20 of the IVRS-based HAM-D (17 items). Subject whose IVRS HAM-D (17 items) total score has not been increased or decreased by >25% during the run-in phase. Subject must have a total score of >=25 on the IDS-SR. Subject must have a score of >=1 on 4 out 5 items on the 5-item subscale of the IDS-SR (Item 19, 20, 21, 22 and 30), and a total score of >=7 on the 5-item subscale of the IDS-SR. Subject must have a CGI-SI score of >=4 (i.e., Moderately ill or much worse). Exclusion Criteria: [At the start time of Run-in phase (Visit 1)] Subject has predispositions to seizure: who currently has or has a past history of seizure or seizure disorder, more than a single febrile seizure in infancy, cerebral tumour, or head / brain injury (traumatic); who has a family history of idiopathic seizure; who is diabetic patient with treating by oral hypoglycaemics or insulin; who uses drugs lowering the threshold of seizure. Subject has a history or current diagnosis of anorexia nervosa (DSM-IV-TR 307.1) or bulimia (DSM-IV-TR 307.51). Subject has a primary DSM-IV diagnosis of, or received treatment for, panic disorder, obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD), or acute stress disorder within 12 months before the start time of Run-in phase. Subject has a DSM-IV diagnosis of schizophrenia, or other psychotic disorder(s) including bipolar disorder. Subject has a history of or currently has manic episode(s). Subject has any other DSM-IV axis II diagnosis that would suggest non-responsiveness to pharmacotherapy or non-compliance with the protocol (e.g., antisocial, borderline disorder or narcissistic personality disorder). Subject starting psychotherapy (except for supportive psychotherapy not aimed at therapeutic efficacy and unlikely to affect efficacy evaluation) or a cognitive behaviour therapy within 12 weeks before start time of the run-in phase. Subject received electroconvulsive therapy (ECT) within 24 weeks before start time of the run-in phase. Subject took MAO inhibitors (selegiline hydrochloride) within 2 weeks before start time of the run-in phase. Subject who has undergone treatment with a depot neuroleptic in the past. Subject has systolic blood pressure of >=160 mmHg or diastolic pressure of >=100 mmHg. Subject 1) is possibly pregnant, 2) is pregnant, lactating, or 3) does not agree to use contraceptive method(s) specified in the protocol to avoid pregnancy during the study (females only). Or subject wants to become pregnant during the study (females only). Subject has a history of alcohol / substance abuse or dependence within 12 months before start time of the run-in phase and/or has a positive result in a urine test for illicit drug use at start time of the run-in phase. Subject, who in the opinion of the investigator (or sub-investigator), poses a current serious suicidal risk or has made a suicide attempt within the past 6 months. Subject took another investigational product for the NDA filing or for the post manufacturing / marketing approval study within 12 weeks before start time of the run-in phase. Subject is currently participating in another clinical study in which the subject is or will be exposed to an investigational or non-investigational drug or medical device. Subject has a history of non-responsiveness to 323U66 SR treatment in the investigational clinical trial for major depressive disorder. Subject has a history of withdrawal from the investigational clinical trial of 323U66 SR for major depressive disorder due to any adverse event(s). Subject has a history of hypersensitivity to 323U66 (bupropion). Subject, who in the opinion of the investigator (or sub-investigator), has a risk of homicide. Subject has serious cerebral disease(s). Subject has serious physical symptom(s) (i.e., cardiac / hepatic / renal / hematopoietic disorder(s)). Subject whose major depressive disorder is due to direct physiological effects of a general medical condition(s) (e.g. hypothyroidism, Parkinson's disease, chronic pain). Subject is complicated by chronic hepatitis B or C being positive in test of hepatitis B surface antigen (HbsAg) or hepatitis C antibody. Subject who is in the process of quitting smoking with nicotine formulation. Subject has previously failed adequate (in terms of dose and duration of therapy) courses of pharmacotherapy with at least two different classes of antidepressants. Subjects undergoing abrupt discontinuation of alcohol or sedatives. Subject is inappropriate for participating in the study that is felt by the investigator (or sub-investigator). [At the start time of the treatment phase] Subject, who in the opinion of the investigator (or sub-investigator), poses a current serious suicidal risk. Subject is inappropriate for participating in the study that is felt by the investigator (or sub-investigator).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Aichi

ZIP/Postal Code

470-1141

Country

Japan

Facility Name

GSK Investigational Site

City

Aichi

ZIP/Postal Code

479-0837

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

802-0006

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

810-0001

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

810-0004

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

810-0022

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

812-0011

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

815-0041

Country

Japan

Facility Name

GSK Investigational Site

City

Fukushima

ZIP/Postal Code

960-0102

Country

Japan

Facility Name

GSK Investigational Site

City

Fukushima

ZIP/Postal Code

961-0021

Country

Japan

Facility Name

GSK Investigational Site

City

Fukushima

ZIP/Postal Code

963-0207

Country

Japan

Facility Name

GSK Investigational Site

City

Hiroshima

ZIP/Postal Code

731-0121

Country

Japan

Facility Name

GSK Investigational Site

City

Hyogo

ZIP/Postal Code

673-0891

Country

Japan

Facility Name

GSK Investigational Site

City

Ibaraki

ZIP/Postal Code

311-3193

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

214-0014

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

221-0835

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

231-0023

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

244-0816

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

251-0055

Country

Japan

Facility Name

GSK Investigational Site

City

Kumamoto

ZIP/Postal Code

861-8002

Country

Japan

Facility Name

GSK Investigational Site

City

Kyoto

ZIP/Postal Code

616-8421

Country

Japan

Facility Name

GSK Investigational Site

City

Nara

ZIP/Postal Code

639-0225

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

545-0001

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

573-0032

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

576-0054

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

589-0011

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

596-0076

Country

Japan

Facility Name

GSK Investigational Site

City

Saga

ZIP/Postal Code

842-0192

Country

Japan

Facility Name

GSK Investigational Site

City

Saga

ZIP/Postal Code

843-0023

Country

Japan

Facility Name

GSK Investigational Site

City

Saga

ZIP/Postal Code

847-0053

Country

Japan

Facility Name

GSK Investigational Site

City

Saitama

ZIP/Postal Code

341-0018

Country

Japan

Facility Name

GSK Investigational Site

City

Shizuoka

ZIP/Postal Code

420-0839

Country

Japan

Facility Name

GSK Investigational Site

City

Tochigi

ZIP/Postal Code

321-0953

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

102-0071

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

110-0003

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

125-0041

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

141-0021

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

142-0051

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

150-0001

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

151-0053

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

154-0004

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

154-0012

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

160-0022

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

160-0023

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

164-0012

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

166-0011

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

170-0002

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

173-0004

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

180-0005

Country

Japan

Facility Name

GSK Investigational Site

City

Gyeonggi-do

ZIP/Postal Code

431-070

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

110-746

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

136-705

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

143-729

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

150-713

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

156-707

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113351

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113351

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113351

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113351

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113351

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

A Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD)

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A Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD)

Depressive Disorder, Major

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial