AZD6765 Severe Major Depressive Disorder (MDD) IV

Study Overview
=================
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).

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

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: AZD6765
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>100 mg iv once per dosing day | Drug: AZD6765<br>* IV once per dosing day, multiple times during the treatment period<br>|
| Experimental: 2<br>150 mg iv once per dosing day | Drug: AZD6765<br>* IV once per dosing day, multiple times during the treatment period<br>|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* 0.9% saline IV once per dosing day multiple times during the treatment period<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Depressive Disorder, MDD