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

NCT00866294 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2017-01-30

Study results available
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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

Interventions

DRUG

paroxetine IR 10mg tablet

1 or 2 tablets once a day

DRUG

paroxetine IR 20mg tablet

1 tablet once a day

DRUG

matched placebo to paroxetine IR 10mg or 20mg

1 or 2 tablets once a day

DRUG

Paroxetine CR 12.5mg tablet

1 or 2 tablets once a day

DRUG

Paroxetine CR 25mg tablet

1 or 2 tablets once a day

DRUG

matched placebo to paroxetine CR 12.5mg or 25mg

1 or 2 tablets once a day

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Japan
  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00866294 on ClinicalTrials.gov