AZD6765 for Treatment Resistant Depression

Depression Clinical Trial

Official title:

A Phase IIa, Multi-Center, Randomized, Double-blind, Placebo-controlled, Parallel-Group Study to Assess the Antidepressant Effect and Onset of Effect of AZD6765 in Treatment-Resistant Major Depressive Disorder Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00491686
• Other study ID #: D6702C00001
• Status: Completed
• Phase: Phase 2
• First received: June 25, 2007
• Last updated: January 20, 2011
• Start date: July 2007
• Est. completion date: November 2007

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether treatment with AZD6765 will have an antidepressant effect with patients who have treatment resistant depression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Depression

• Inadequate response to an adequate course of antidepressants

Exclusion Criteria:

• Psychiatric disorder other than depression

• Pregnancy or lactation

• Current diagnosis of cancer

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant

Intervention

Drug:
• AZD6765
intravenous infusion

Locations

Country	Name	City	State
United States	Research Site	Glendale	California
United States	Research Site	Hartford	Connecticut
United States	Research Site	New Haven	Connecticut
United States	Research Site	Rockville	Maryland
United States	Research Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to determine whether an antidepressant effect can be achieved in patients with Treatment Resistant Depression determined by a change from baseline in the MADRS total score.		Change from Baseline
Secondary	The secondary objective is to assess the safety and tolerability of AZD6765 as assessed by vital signs, physical examination, clinical laboratory evaluations, ECG's and incidence of adverse events.		each visit; change from baseline