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

AstraZeneca

Status and phase: Terminated; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: AZD2066; Drug: Duloxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01145755

D0475C00020

Details and patient eligibility

About

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

Full 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.

Enrollment: 131 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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131 participants in 3 patient groups, including a placebo group

AZD2066

Experimental group

Treatment:

Drug: AZD2066

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Duloxetine

Active Comparator group

Description:

Duloxetine

Treatment:

Drug: Duloxetine