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

Major Depressive Disorder Clinical Trial

Official title:

A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Effectiveness and Safety of AZD2066 After 6 Weeks of Treatment in Patients With Major Depressive Disorder - D0475C00020

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01145755
• Other study ID #: D0475C00020
• Status: Terminated
• Phase: Phase 2
• First received: May 27, 2010
• Last updated: September 27, 2012
• Start date: May 2010
• Est. completion date: November 2010

Study information

• Verified date: September 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 131
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• AZD2066
18 mg once daily
• Placebo

• Duloxetine
60 mg once daily

Locations

Country	Name	City	State
United States	Research Site	Atlanta	Georgia
United States	Research Site	Bellevue	Washington
United States	Research Site	Boston	Massachusetts
United States	Research Site	Cedarhurst	New York
United States	Research Site	Friendswood	Texas
United States	Research Site	Garden Grove	California
United States	Research Site	Jacksonville	Florida
United States	Research Site	Memphis	Tennessee
United States	Research Site	Portland	Oregon
United States	Research Site	Rochester	New York
United States	Research Site	Rockville	Maryland
United States	Research Site	San Diego	California
United States	Research Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MADRS Total Score Change From Baseline to Week 6	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.	6 weeks	No
Secondary	MADRS Response	A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.	6 weeks	No
Secondary	MADRS Remission	A patient will be classified as in remission if their MADRS total score is =10 at Week 6	6 weeks	No