Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive Disorder (MOONSTONE)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Quetiapine fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00320268

Moonstone

D1448C00001

Details and patient eligibility

About

This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has a documented clinical diagnosis of Major Depressive Disorder.
• Be able to understand and comply with the requirements of the study.
• Able to understand and provide written informed consent

Exclusion criteria

• Patients (female) must not be pregnant or lactating
• Current or past diagnosis of stroke or transient ischemic attack (TIA).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind