AZD6765 for Treatment Resistant Depression

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00491686
• Collaborator: (none)
• Enrollment: 34
• Locations: 5
• Duration (Months): 4
• Patients Per Site: 6.8
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: AZD6765	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Nov 1, 2007

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Glendale	California	United States
2	Research Site	Hartford	Connecticut	United States
3	Research Site	New Haven	Connecticut	United States
4	Research Site	Wichita	Kansas	United States
5	Research Site	Rockville	Maryland	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Mark Smith, MD, PhD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00491686
• Other Study ID Numbers: D6702C00001
• First Posted: Jun 26, 2007
• Last Update Posted: Jan 21, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: Long-term depression
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

No Results Posted as of Jan 21, 2011