6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder

Phase 2

Terminated

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: Duloxetine; Drug: AZD2066

• Registration Number: NCT01145755
• Lead Sponsor: AstraZeneca

Brief Summary

This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.

Detailed Description

A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, parallel Group Study to Assess the Efficacy and Safety of AZD2066 after 6 weeks of treatment in Patients with Major Depressive Disorder - D0475C00020.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-27
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2012-08-28
• Results First Submitted QC: 2012-08-28
• Status Verified: 2012-09
• Results First Posted: 2012-09-27
• Last Update Submitted: 2012-09-27
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

• Provision of signed, written, and dated Informed Consent
• Documented primary clinical diagnosis of Major Depressive Disorder

Exclusion Criteria

• Patients with a secondary psychiatric disorder including bipolar disorder, psychotic disorders (i.e. schizophrenia, schizoaffective disorder, depression with psychotic features), GAD and social anxiety disorder
• Patients whose current episode of depression started less than 4 weeks before enrollment
• History of inadequate response of antidepressants during current depressive episode

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Duloxetine	Duloxetine	Duloxetine
AZD2066	AZD2066	-

Primary Outcome Measures

Name	Time	Method
MADRS Total Score Change From Baseline to Week 6	6 weeks	Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.

Secondary Outcome Measures

Name	Time	Method
MADRS Response	6 weeks	A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.
MADRS Remission	6 weeks	A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6

Trial Locations

Locations (1)

Research Site; 🇺🇸 Seattle, Washington, United States