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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depressive Disorder

Intervention: paroxetine IR 10mg tablet (Drug); paroxetine IR 20mg tablet (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 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

Official title: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Clinical Effects of Controlled Release Paroxetine in the Treatment of Major Depressive Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8

Secondary outcome:

Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8

Percentage of HAM-D Responders at Weeks 4 and 8

Percentage of HAM-D Remitters at 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

Percentage of Responders Based on the Clinical Global Impression-Global Improvement (CGI-GI) Scores at Weeks 4 and 8

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 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]) 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.

- Patients whose HAM-D (17 items) total score is >=20 points

- Patients whose score of "depressed mood" (HAM-D Item 1) is >=2 points

Exclusion Criteria: 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

- Patients with a convulsive disorder such as epilepsy or a history of it

- Patients using a drug increasing an onset risk of bleeding, patients with a bleeding

tendency or bleeding diathesis

- Patients complicated with severe renal or hepatic dysfunction

- Patients complicated with serious organic brain disorder

- Patients with a history or complication of cancer or malignant tumor

- Patients complicated by chronic hepatitis B or C being positive in test of hepatitis

B surface antigen (HbsAg) or hepatitis C antibody

- Pregnant, lactating or possibly pregnant female patients, and female patients wishing

to be pregnant during the study period

- Patients who have previously been unresponsive to paroxetine therapy (e. g. >4wks

unresponsive to paroxetine for depression).

- Patients with a history of having discontinued treatment due to an adverse event

caused by paroxetine

- Patients with a history of hypersensitivity to paroxetine.

- Patients judged ineligible to participate in this study by the investigator or

subinvestigator Exclusion criteria < at the start of treatment phase> The patients who are meeting any of the following conditions at Week 0 (at the start of treatment phase) must not be allowed to the treatment phase.

- Patients with a 3 or more-point score of "suicide" (HAM-D Item 3) or with a strong

suicidal tendency by C-SSRS and investigator clinical judgement.

- Patients whose HAM-D (17 items) total score at the Week 0 visit has changed ±25 %, or

exceeding the range of ±25 % of the score at the Week - 1 visit

- Patients whose Drug 1 (run-in placebo) compliance rate in the period from Week -1 to

Week 0 has been < 80 %

- Patients judged ineligible as the study subjects by the investigator or

subinvestigator

Locations and Contacts

GSK Investigational Site, Aichi 453-0015, Japan

GSK Investigational Site, Aichi 468-0045, Japan

GSK Investigational Site, Aichi 479-0837, Japan

GSK Investigational Site, Chiba 272-0133, Japan

GSK Investigational Site, Fukuoka 802-0084, Japan

GSK Investigational Site, Fukuoka 802-8533, Japan

GSK Investigational Site, Fukuoka 810-0001, Japan

GSK Investigational Site, Fukuoka 810-0022, Japan

GSK Investigational Site, Fukuoka 811-0121, Japan

GSK Investigational Site, Fukuoka 815-0041, Japan

GSK Investigational Site, Fukuoka 819-0167, Japan

GSK Investigational Site, Gunma 379-0115, Japan

GSK Investigational Site, Hokkaido 060-0003, Japan

GSK Investigational Site, Hokkaido 060-0042, Japan

GSK Investigational Site, Hokkaido 063-0804, Japan

GSK Investigational Site, Hyogo 651-0097, Japan

GSK Investigational Site, Hyogo 657-0846, Japan

GSK Investigational Site, Hyogo 660-0882, Japan

GSK Investigational Site, Ibaraki 311-3193, Japan

GSK Investigational Site, Kanagawa 220-0004, Japan

GSK Investigational Site, Kanagawa 221-0835, Japan

GSK Investigational Site, Kanagawa 223-0052, Japan

GSK Investigational Site, Kanagawa 231-0023, Japan

GSK Investigational Site, Kanagawa 238-0042, Japan

GSK Investigational Site, Kanagawa 244-0816, Japan

GSK Investigational Site, Kanagawa 251-0055, Japan

GSK Investigational Site, Kumamoto 861-8002, Japan

GSK Investigational Site, Kyoto 616-8421, Japan

GSK Investigational Site, Nagano 390-0303, Japan

GSK Investigational Site, Nagano 399-8695, Japan

GSK Investigational Site, Osaka 530-0041, Japan

GSK Investigational Site, Osaka 569-7711, Japan

GSK Investigational Site, Osaka 582-0025, Japan

GSK Investigational Site, Osaka 589-0011, Japan

GSK Investigational Site, Saga 840-0816, Japan

GSK Investigational Site, Saga 843-0023, Japan

GSK Investigational Site, Saitama 331-0081, Japan

GSK Investigational Site, Saitama 332-0012, Japan

GSK Investigational Site, Saitama 350-0046, Japan

GSK Investigational Site, Saitama 366-0824, Japan

GSK Investigational Site, Tochigi 321-0953, Japan

GSK Investigational Site, Tokyo 135-0061, Japan

GSK Investigational Site, Tokyo 107-0052, Japan

GSK Investigational Site, Tokyo 167-0051, Japan

GSK Investigational Site, Tokyo 141-0021, Japan

GSK Investigational Site, Tokyo 142-0051, Japan

GSK Investigational Site, Tokyo 151-0053, Japan

GSK Investigational Site, Tokyo 152-0012, Japan

GSK Investigational Site, Tokyo 154-0004, Japan

GSK Investigational Site, Tokyo 165-0033, Japan

GSK Investigational Site, Tokyo 166-0003, Japan

GSK Investigational Site, Tokyo 167-0042, Japan

GSK Investigational Site, Tokyo 170-0002, Japan

GSK Investigational Site, Tokyo 173-0037, Japan

GSK Investigational Site, Tokyo 180-0005, Japan

GSK Investigational Site, Tokyo 192-0082, Japan

GSK Investigational Site, Tokyo 100-0006, Japan

GSK Investigational Site, Tottori 682-0023, Japan

GSK Investigational Site, Gwangju 501-757, Korea, Republic of

GSK Investigational Site, Seoul 110-744, Korea, Republic of

GSK Investigational Site, Seoul 156-707, Korea, Republic of

GSK Investigational Site, Seoul 135-710, Korea, Republic of

GSK Investigational Site, Seoul 136-705, Korea, Republic of

GSK Investigational Site, Seoul 137-701, Korea, Republic of

GSK Investigational Site, Seoul 138-736, Korea, Republic of

GSK Investigational Site, Seoul 150-713, Korea, Republic of

GSK Investigational Site, Seoul 110-746, Korea, Republic of

Additional Information

Related publications:

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.

Starting date: April 2009
Last updated: May 29, 2014

Page last updated: August 23, 2015

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