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A Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD)

NCT01138007 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2018-08-10

Study results available
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Summary

This is a multi-center, placebo-controlled, randomized, double-blind, parallel-comparison study to confirm the efficacy of 323U66 Sustained Release (SR) orally administered to patients with MDD (Major Depressive Disorder) at doses level of 150 mg/day and 300 mg/day for 8 weeks based on the decrease in MADRS (Montgomery-Asberg Depression Rating Scale) total score, and to evaluate the safety based on adverse events, clinical laboratory tests and vital signs.

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

323U66 SR 150 mg tablet

323U66 SR 150 mg tablet is orally administered once in the morning and/or once in the evening during the teatment phase.

DRUG

323U66 SR 150 mg placebo tablet

323U66 SR 150 mg placebo tablet is orally administered once in the evening and/or once in the morning during the teatment phase.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-17
Primary Completion
2012-08-01
Completion
2012-08-07

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 NCT01138007 on ClinicalTrials.gov