Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT01138007 |
Date of registration:
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03/06/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD)
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Scientific title:
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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 |
Date of first enrolment:
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June 17, 2010 |
Target sample size:
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572 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01138007 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Japan
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Korea, Republic of
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Contacts
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Name:
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GSK Clinical Trials |
Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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 t
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Depressive Disorder, Major
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Intervention(s)
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Drug: 323U66 SR 150 mg tablet
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Drug: 323U66 SR 150 mg placebo tablet
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Primary Outcome(s)
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Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8/Withdrawal
[Time Frame: Baseline and Week 8/Withdrawal]
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Secondary Outcome(s)
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Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
[Time Frame: Baseline; Week 1, 2, 4, 6, and 8]
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Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 4, 6, and 8
[Time Frame: Baseline; Weeks 1, 2, 4, 6, and 8]
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Number of Clinical Global Impression-Global Improvement (CGI-GI) Responders at Week 8
[Time Frame: Week 8]
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Number of MADRS Remitters at Week 8
[Time Frame: Week 8]
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Change From Baseline in the Inventory of Depressive Symptomatology-Self Report (IDS-SR) Total Score at Weeks 1, 2, 4, 6, and 8
[Time Frame: Baseline; Weeks 1, 2, 4, 6, and 8]
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Change From Baseline in the IDS-SR Subscores for Energy, Pleasure, and Interest at Weeks 1, 2, 4, 6, and 8
[Time Frame: Baseline; Weeks 1, 2, 4, 6, and 8]
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Change From Baseline in the MADRS Total Score at Weeks 1, 2, 4, and 6
[Time Frame: Baseline; Weeks 1, 2, 4, and 6]
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Number of MADRS Responders at Week 8
[Time Frame: Baseline and Week 8]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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