A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Clinical Effects of Controlled Release Paroxetine in the Treatment of Major Depressive Disorder
Overview
- Phase
- Phase 3
- Intervention
- paroxetine IR 20mg tablet
- Conditions
- Depressive Disorder
- Sponsor
- GlaxoSmithKline
- Enrollment
- 416
- Locations
- 1
- Primary Endpoint
- Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of controlled-release (CR) formulation of paroxetine orally administered to patients with major depressive disorder (MDD) at a dose level in the range of 25 - 50 mg/day (initial dose level, 12.5 or 25 mg/day) once daily after evening meal for 8 weeks based on the decrease in HAM-D (Hamilton Depression Rating Scale) total score, to evaluate the safety based on adverse events, laboratory data and vital signs, and to describe the efficacy and safety of immediate release (IR) formulation of paroxetine.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\<at the start of placebo run-in phase\> Only the patients who meet all of the following conditions at Week -1 (at the start of placebo run-in phase) will be enrolled in this study. The hospitalization status will be no object. and Gender: No object.
- •Target disease: Patients diagnosed as having one of the following depressive disorders based on DSM-IV-TR classification in conjunction with M.I.N.I. (The Mini International Neuropsychiatric Interview, Japanese version 5.0.
- •\[2003\]) and showing currently a symptom of depression or depressed sate
- •Major depressive disorder, single episode (296.2) (excluding those accompanied by comorbid psychiatric disorders)
- •Major depressive disorder, recurrent (296.3) (excluding those accompanied by comorbid psychiatric disorders)
- •Age: \>= 20 years (at the time of obtaining consent)
- •Consent: Patients from whom written consent to participate in this study can be obtained
- •Female patients of childbearing potential can be enrolled. But, such patients who can be enrolled are limited to only those who are negative in the pregnancy test performed at the start of the placebo run-in phase and who agree to receive a pregnancy test at the time point defined in the study period and surely perform any of the contraceptive methods.
- •Male subjects must abstain from (or use a condom during) sexual intercourse with a pregnant or lactating female. Male subjects must abstain from or use a condom plus spermicidal agent (foam/gel/film/cream/suppository) during sexual intercourse with a female of child-bearing potential.
- •Patients whose HAM-D (17 items) total score is \>= 20 points
Exclusion Criteria
- •\<at the start of placebo run-in phase\> The patients who are meeting any of the following conditions at Week -1 (at the start of placebo run-in phase) must not be enrolled in this study.
- •Patients whose primary diagnosis is a disorder classified to Axis I other than major depressive disorder in DSM-IV-TR classification (dysthymic disorder, eating disorder, specific phobia (monophobia), posttraumatic stress disorder, obsessive-compulsive disorder, panic disorder, etc.)
- •Patients with a current DSM-IV-TR Axis II diagnosis that suggested non-responsiveness to pharmacotherapy or non- compliance with the protocol (e.g., antisocial or borderline personality disorder)
- •Patients with a history or complication of another (non-MDD) mental disorder (schizophrenia, etc.)
- •Patients with a history or complication of manic episodes
- •Patients diagnosed as having an attentional deficit disorder or hyperactivity disorder
- •Patients diagnosed as having a pervasive development disorder or mental retardation
- •Patients diagnosed as abusing or dependent on alcohol or drug within one year before the Week -1 visit
- •Patients who have undergone electroconvulsive therapy within one year before the Week -1 visit for the treatment of the current episode
- •Patients who have a history of treatment with depot neuroleptics
Arms & Interventions
paroxetine IR group
Immediate-release (IR) of paroxetine 10 to 40mg/day as a reference arm
Intervention: paroxetine IR 20mg tablet
paroxetine CR group
controlled-release (CR) of paroxetine 12.5 to 50mg/day
Intervention: matched placebo to paroxetine IR 10mg or 20mg
paroxetine CR group
controlled-release (CR) of paroxetine 12.5 to 50mg/day
Intervention: Paroxetine CR 12.5mg tablet
paroxetine CR group
controlled-release (CR) of paroxetine 12.5 to 50mg/day
Intervention: Paroxetine CR 25mg tablet
paroxetine CR group
controlled-release (CR) of paroxetine 12.5 to 50mg/day
Intervention: matched placebo to paroxetine CR 12.5mg or 25mg
paroxetine IR group
Immediate-release (IR) of paroxetine 10 to 40mg/day as a reference arm
Intervention: paroxetine IR 10mg tablet
paroxetine IR group
Immediate-release (IR) of paroxetine 10 to 40mg/day as a reference arm
Intervention: matched placebo to paroxetine IR 10mg or 20mg
paroxetine IR group
Immediate-release (IR) of paroxetine 10 to 40mg/day as a reference arm
Intervention: matched placebo to paroxetine CR 12.5mg or 25mg
placebo group
matched placebo to both paroxetine CR and paroxetine IR
Intervention: matched placebo to paroxetine IR 10mg or 20mg
placebo group
matched placebo to both paroxetine CR and paroxetine IR
Intervention: matched placebo to paroxetine CR 12.5mg or 25mg
Outcomes
Primary Outcomes
Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8
Time Frame: Baseline (Week 0) and Week 8
The HAM-D measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at Week 8 minus the Baseline value.
Secondary Outcomes
- Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8(Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8)
- Percentage of HAM-D Responders at Weeks 4 and 8(Weeks 4 and 8)
- Percentage of HAM-D Remitters at Weeks 4 and 8(Weeks 4 and 8)
- Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8(Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8)
- Percentage of Responders Based on the Clinical Global Impression-Global Improvement (CGI-GI) Scores at Weeks 4 and 8(Weeks 4 and 8)