AZD6765 Severe Major Depressive Disorder (MDD) IV

Major Depressive Disorder Clinical Trial

Official title:

A Phase IIb, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Efficacy and Safety Study of Adjunctive AZD6765 in Subjects With Severe Major Depressive Disorder (MDD) and a History of Poor Response to Antidepressants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781742
• Other study ID #: D6702C00009
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2008
• Last updated: July 16, 2012
• Start date: October 2008
• Est. completion date: March 2010

Study information

• Verified date: July 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to determine whether AZD6765 has an effect on the patient's depression when taken together with current depression medication. In addition, information will be gathered on how well AZD6765 is tolerated, investigate the levels of AZD6765 and the levels of the current depression medication in the blood. In addition, the research staff will determine if AZD6765 has any mood or calming effects (how you feel).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Signed informed consent before any study-related procedures start.

• The patient is previously diagnosed with Major Depressive Disorder (MDD) and currently taking an antidepressant for at least 6 weeks.

• Patient has a history of poor response to 1 or more antidepressants (in addition to the antidepressant the patient is taking at enrollment) after exposure at adequate doses or maximum tolerated doses for =4 weeks.

Exclusion Criteria:

• Patient has a lifetime history of schizophrenia, bipolar, psychosis or psychotic depression.

• Patient has a lifetime history of failure to ECT therapy.

• Patient is pregnant or breast feeding.

• Length of current episode of depression exceeds =2 years.

Related Conditions & MeSH terms

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

Intervention

Drug:
• AZD6765
IV once per dosing day, multiple times during the treatment period
• Placebo
0.9% saline IV once per dosing day multiple times during the treatment period

Locations

Country	Name	City	State
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Atlanta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Boca Raton	Florida
United States	Research Site	Dallas	Texas
United States	Research Site	East Stroudsburg	Pennsylvania
United States	Research Site	Gainsville	Florida
United States	Research Site	Hartford	Connecticut
United States	Research Site	Haverhill	Massachusetts
United States	Research Site	Hoffman Estates	Illinois
United States	Research Site	Hollywood	Florida
United States	Research Site	Jacksonville	Florida
United States	Research Site	Joliet	Illinois
United States	Research Site	Lake Charles	Louisiana
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Los Angeles	California
United States	Research Site	New Haven	Connecticut
United States	Research Site	Orange	California
United States	Research Site	Overland Park	Kansas
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Rochester	New York
United States	Research Site	Roswell	Georgia
United States	Research Site	San Diego	California
United States	Research Site	Santa Ana	California
United States	Research Site	Shreveport	Louisiana
United States	Research Site	St. Louis	Missouri
United States	Research Site	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score		Baseline to week 3
Secondary	To determine if the antidepressant effect can be achieved at week 3 with AZD6765 (100 or 150 mg/infusion) versus placebo by assessing a change from baseline to week 3 in the MADRS total score.		3 weeks
Secondary	To evaluate the rapid antidepressant efficacy of AZD6765 at 1 day after a first infusion, as assessed by a change in the Quick Inventory of Depressive Symptomology Self-Report 16-item scale (QIDS-SR-16) total score.		baseline to Day 1
Secondary	• To assess the safety and tolerability of multiple infusions when administered concomitantly with other anti-depressants by incidence of AEs.		8 weeks