AZD6765 Severe Major Depressive Disorder (MDD) IV

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: AZD6765; Drug: Placebo

• Registration Number: NCT00781742
• Lead Sponsor: AstraZeneca

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-27
• Study First Submitted QC: 2008-10-28
• Study First Posted: 2008-10-29
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Disposition First Submitted: 2012-02-21
• Disposition First Submitted QC: 2012-02-21
• Disposition First Posted: 2012-02-23
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD6765	100 mg iv once per dosing day
3	Placebo	-
2	AZD6765	150 mg iv once per dosing day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
• To assess the safety and tolerability of multiple infusions when administered concomitantly with other anti-depressants by incidence of AEs.	8 weeks

Trial Locations

Locations (1)

Research Site; 🇺🇸 Dallas, Texas, United States