Trial intelligence / Profile preview

MK-0869 (Aprepitant) in Major Depressive Disorder

NCT00048607Phase 3

Key facts

Status: Completed
Start: Jul 2002
Primary completion: Dec 2003
Sponsor: Merck & Co.
Modality: Small Molecules

Drugs: aprepitant
Conditions: major depressive disorder (MDD)

Overview

Phase 3, randomised, double-blind trial of aprepitant in major depressive disorder (MDD) (4 arms), sponsored by Merck & Co. Primary endpoints: Hamilton Depression Rating Scale 17-Item at 8 weeks and Tolerability at 8 weeks. Started Jul 2002; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

MK-0869 Dose 1
MK-0869 (aprepitant) at Dose 1
MK-0869 Dose 2
MK-0869 (aprepitant) at Dose 2
Paroxetine
Active Comparator: Paroxetine HCL
Placebo
Placebo Comparator

Who it enrols

Patients with Major Depressive Disorder.

Endpoints

Primary

Hamilton Depression Rating Scale 17-Item8 weeks
Tolerability8 weeks

Secondary

Clinical Global Impressions-Improvement Scale8 weeks
Sheehan Disability Scale8 weeks

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