CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 416 enrolled
Drug / intervention
paroxetine IR 10mg tablet +5 moredrug
Likely dose
paroxetine IR 10mg tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00866294
NCT00866294Phase 3Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Mar 20, 2009·Updated Jan 30, 2017

In Brief

A Phase 3 clinical trial evaluating paroxetine IR 10mg tablet, paroxetine IR 20mg tablet, and 4 other interventions for Depressive Disorder. Completed, enrolled 416 participants across 67 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder
CountriesJapan, South Korea
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 20, 2009
Enrollment StartApr 1, 2009
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.3 years ago

Interventions

paroxetine IR 10mg tabletdrug

1 or 2 tablets once a day

paroxetine IR 20mg tabletdrug

1 tablet once a day

matched placebo to paroxetine IR 10mg or 20mgdrug

1 or 2 tablets once a day

Paroxetine CR 12.5mg tabletdrug

1 or 2 tablets once a day

Paroxetine CR 25mg tabletdrug

1 or 2 tablets once a day

matched placebo to paroxetine CR 12.5mg or 25mgdrug

1 or 2 tablets once a day