Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study)

NCT00866294 | Completed Phase 3 Results

• 1 other identifier: 112810
• Study Type: interventional
• Target: 416
• Locations: 2 countries
• Sites: 67

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.

Conditions

Depressive Disorder

Keywords

Immediate-release formulation of paroxetine (paroxetine IR); HAM-D (17 items); Controlled-release formulation of paroxetine (paroxetine CR)

Outcome Measures

Primary Outcomes (1)

• Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at 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.

  Baseline (Week 0) and Week 8

Secondary Outcomes (5)

• 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

Study Arms (3)

paroxetine CR group

EXPERIMENTAL

controlled-release (CR) of paroxetine 12.5 to 50mg/day

Drug: matched placebo to paroxetine IR 10mg or 20mg; Drug: Paroxetine CR 12.5mg tablet; Drug: Paroxetine CR 25mg tablet; Drug: matched placebo to paroxetine CR 12.5mg or 25mg

paroxetine IR group

OTHER

Immediate-release (IR) of paroxetine 10 to 40mg/day as a reference arm

Drug: paroxetine IR 10mg tablet; Drug: paroxetine IR 20mg tablet; Drug: matched placebo to paroxetine IR 10mg or 20mg; Drug: matched placebo to paroxetine CR 12.5mg or 25mg

placebo group

PLACEBO COMPARATOR

matched placebo to both paroxetine CR and paroxetine IR

Drug: matched placebo to paroxetine IR 10mg or 20mg; Drug: matched placebo to paroxetine CR 12.5mg or 25mg

Interventions

paroxetine IR 10mg tablet DRUG

1 or 2 tablets once a day

paroxetine IR group

paroxetine IR 20mg tablet DRUG

1 tablet once a day

paroxetine IR group

matched placebo to paroxetine IR 10mg or 20mg DRUG

1 or 2 tablets once a day

paroxetine CR group; paroxetine IR group; placebo group

Paroxetine CR 12.5mg tablet DRUG

1 or 2 tablets once a day

paroxetine CR group

Paroxetine CR 25mg tablet DRUG

1 or 2 tablets once a day

paroxetine CR group

matched placebo to paroxetine CR 12.5mg or 25mg DRUG

1 or 2 tablets once a day

paroxetine CR group; paroxetine IR group; placebo group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<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 5.0.0. \[2003\]) 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
• Gender:
• 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
• Patients whose duration of current episode at least 12 weeks but no longer than 24 months
• Patients whose score of "depressed mood" (HAM-D Item 1) is \>= 2 points
• QTc\<450 millisecond (msec) or \<480 msec for patients with Bundle Branch Block - values based on either single ECG values or triplicate ECG averaged QTc values obtained over a brief recording period.
• For the purposes of these criteria, QTc B (Bazett's correction) is defined as (QT interval \[msec\]) /(square root of RR interval \[seconds\])
• \<at the start of treatment phase\> Only the patients who meet all of the following conditions at Week -1 (at the start of the placebo run-in phase) and Week 0 (at the start of treatment phase) can be shifted to the treatment phase.

You may not qualify if:

• \<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
• Patients with a history of serotonin syndrome or neuroleptic malignant syndrome
• Patients with a \>= 3-point score of "suicide" (HAM-D Item 3) or patients whose Columbia Suicide Severity Rating Scale (C-SSRS) assessment suggests that they are or have been at significant risk for harming themselves or have actually harmed themselves, or who, in the opinion of the investigator (subinvestigator), are at significant risk for harming self or others.
• Patients with a history of suicide attempt, self-injurious action (excluding action with no intention of suicide) or overdosage (excluding apparently accidental overdosage)
• Patients who have taken another investigational product or a drug used in a post-marketing clinical study within 12 weeks before the Week -1 visit
• Patients with glaucoma

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (67)

GSK Investigational Site

Aichi, 453-0015, Japan

Location

GSK Investigational Site

Aichi, 468-0045, Japan

Location

GSK Investigational Site

Aichi, 479-0837, Japan

Location

GSK Investigational Site

Chiba, 272-0133, Japan

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GSK Investigational Site

Fukuoka, 802-0084, Japan

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GSK Investigational Site

Fukuoka, 802-8533, Japan

Location

GSK Investigational Site

Fukuoka, 810-0001, Japan

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GSK Investigational Site

Fukuoka, 810-0022, Japan

Location

GSK Investigational Site

Fukuoka, 811-0121, Japan

Location

GSK Investigational Site

Fukuoka, 815-0041, Japan

Location

GSK Investigational Site

Fukuoka, 819-0167, Japan

Location

GSK Investigational Site

Gunma, 379-0115, Japan

Location

GSK Investigational Site

Hokkaido, 060-0003, Japan

Location

GSK Investigational Site

Hokkaido, 060-0042, Japan

Location

GSK Investigational Site

Hokkaido, 063-0804, Japan

Location

GSK Investigational Site

Hyōgo, 651-0097, Japan

Location

GSK Investigational Site

Hyōgo, 657-0846, Japan

Location

GSK Investigational Site

Hyōgo, 660-0882, Japan

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GSK Investigational Site

Ibaraki, 311-3193, Japan

Location

GSK Investigational Site

Kanagawa, 220-0004, Japan

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GSK Investigational Site

Kanagawa, 221-0835, Japan

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GSK Investigational Site

Kanagawa, 223-0052, Japan

Location

GSK Investigational Site

Kanagawa, 231-0023, Japan

Location

GSK Investigational Site

Kanagawa, 238-0042, Japan

Location

GSK Investigational Site

Kanagawa, 244-0816, Japan

Location

GSK Investigational Site

Kanagawa, 251-0055, Japan

Location

GSK Investigational Site

Kumamoto, 861-8002, Japan

Location

GSK Investigational Site

Kyoto, 616-8421, Japan

Location

GSK Investigational Site

Nagano, 390-0303, Japan

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GSK Investigational Site

Nagano, 399-8695, Japan

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GSK Investigational Site

Osaka, 530-0041, Japan

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GSK Investigational Site

Osaka, 569-7711, Japan

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GSK Investigational Site

Osaka, 582-0025, Japan

Location

GSK Investigational Site

Osaka, 589-0011, Japan

Location

GSK Investigational Site

Saga, 840-0816, Japan

Location

GSK Investigational Site

Saga, 843-0023, Japan

Location

GSK Investigational Site

Saitama, 331-0081, Japan

Location

GSK Investigational Site

Saitama, 332-0012, Japan

Location

GSK Investigational Site

Saitama, 350-0046, Japan

Location

GSK Investigational Site

Saitama, 366-0824, Japan

Location

GSK Investigational Site

Tochigi, 321-0953, Japan

Location

GSK Investigational Site

Tokyo, 100-0006, Japan

Location

GSK Investigational Site

Tokyo, 107-0052, Japan

Location

GSK Investigational Site

Tokyo, 135-0061, Japan

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GSK Investigational Site

Tokyo, 141-0021, Japan

Location

GSK Investigational Site

Tokyo, 142-0051, Japan

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GSK Investigational Site

Tokyo, 151-0053, Japan

Location

GSK Investigational Site

Tokyo, 152-0012, Japan

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GSK Investigational Site

Tokyo, 154-0004, Japan

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GSK Investigational Site

Tokyo, 165-0033, Japan

Location

GSK Investigational Site

Tokyo, 166-0003, Japan

Location

GSK Investigational Site

Tokyo, 167-0042, Japan

Location

GSK Investigational Site

Tokyo, 167-0051, Japan

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GSK Investigational Site

Tokyo, 170-0002, Japan

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GSK Investigational Site

Tokyo, 173-0037, Japan

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GSK Investigational Site

Tokyo, 180-0005, Japan

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GSK Investigational Site

Tokyo, 192-0082, Japan

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GSK Investigational Site

Tottori, 682-0023, Japan

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GSK Investigational Site

Gwangju, 501-757, South Korea

Location

GSK Investigational Site

Seoul, 110-744, South Korea

Location

GSK Investigational Site

Seoul, 110-746, South Korea

Location

GSK Investigational Site

Seoul, 135-710, South Korea

Location

GSK Investigational Site

Seoul, 136-705, South Korea

Location

GSK Investigational Site

Seoul, 137-701, South Korea

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GSK Investigational Site

Seoul, 138-736, South Korea

Location

GSK Investigational Site

Seoul, 150-713, South Korea

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GSK Investigational Site

Seoul, 156-707, South Korea

Location

Related Publications (1)

• Higuchi T, Hong JP, Jung HY, Watanabe Y, Kunitomi T, Kamijima K. Paroxetine controlled-release formulation in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled study in Japan and Korea. Psychiatry Clin Neurosci. 2011 Dec;65(7):655-63. doi: 10.1111/j.1440-1819.2011.02243.x. Epub 2011 Sep 6.

  PMID: 21895859 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Depressive Disorder

Interventions

Tablets

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

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: March 19, 2009
• First Posted: March 20, 2009
• Study Start: April 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: January 30, 2017
• Results First Posted: November 15, 2010

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

KR (9); JP (58)