Trial intelligence / Profile preview

AZD6765 in Treatment-Resistant Major Depression

NCT00986479Phase 2

Key facts

Status: Completed
Start: Dec 2009
Primary completion: Dec 2011
Countries: 1
Sponsor: AstraZeneca
Modality: Small Molecules

Drugs: lanicemine
Conditions: major depressive disorder (MDD)

Overview

Phase 2, randomised, double-blind trial of lanicemine in major depressive disorder (MDD) (2 arms), sponsored by AstraZeneca. Primary endpoint: Montgomery-Asberg Depression Rating Scale Total Score at 7 days. Started Dec 2009; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

AZD6765 / Placebo
AZD6765 in Period 1, Placebo in Period 2
Placebo / AZD6765
Placebo in Period 1, AZD6765 in Period 2

Who it enrols

Patients with treatment-resistant Major Depressive Disorder, currently depressed without psychotic features. Females must be of non-childbearing potential.

Endpoints

Primary

Montgomery-Asberg Depression Rating Scale Total Score7 days

Secondary

Proportion of Participants with MADRS Total Score < 107 days
Proportion of Participants with >= 50% Reduction in MADRS Total Score7 days
Scale for Suicide Ideation Total Score7 days
Hamilton Anxiety Rating Scale Total Score7 days
Hamilton Depression Rating Scale-17 Item Total Score7 days
Visual Analogue Scale Depressed Score7 days
Clinician-Administered Dissociative States Scale Score7 days
Brief Psychiatric Rating Scale Score7 days

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