Skip to main content
OpenTrials
Completed

NCT Number: NCT00320268

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Quetiapine fumarate

Drug

Primary outcomes

  1. Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score

Secondary outcomes

  1. Change from randomization to each assessment in the MADRS total score

  2. MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained-Release (SEROQUEL®) as Monotherapy in the Treatment of Patients With MDD

Acronym: MOONSTONE

Important dates

Study start
2006
Study completion
2007
First posted
May 3, 2006
Registry last updated
Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.