MedDataX Logo

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

NCT ID: NCT01145755

Last Updated: 2012-10-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AZD2066

Group Type EXPERIMENTAL

AZD2066

Intervention Type DRUG

18 mg once daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Duloxetine

Duloxetine

Group Type ACTIVE_COMPARATOR

Duloxetine

Intervention Type DRUG

60 mg once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD2066

18 mg once daily

Intervention Type DRUG

Placebo

Intervention Type DRUG

Duloxetine

60 mg once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Richard Malamut

Role: STUDY_CHAIR

AstraZeneca

Lora McGill

Role: PRINCIPAL_INVESTIGATOR

CNS Healthcare

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Garden Grove, California, United States

Site Status

Research Site

San Diego, California, United States

Site Status

Research Site

Jacksonville, Florida, United States

Site Status

Research Site

Atlanta, Georgia, United States

Site Status

Research Site

Rockville, Maryland, United States

Site Status

Research Site

Boston, Massachusetts, United States

Site Status

Research Site

Cedarhurst, New York, United States

Site Status

Research Site

Rochester, New York, United States

Site Status

Research Site

Portland, Oregon, United States

Site Status

Research Site

Memphis, Tennessee, United States

Site Status

Research Site

Friendswood, Texas, United States

Site Status

Research Site

Bellevue, Washington, United States

Site Status

Research Site

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D0475C00020

Identifier Type: -

Identifier Source: org_study_id