6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.

Detailed Description
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A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, parallel Group Study to Assess the Efficacy and Safety of AZD2066 after 6 weeks of treatment in Patients with Major Depressive Disorder - D0475C00020.

Official Title
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A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Effectiveness and Safety of AZD2066 After 6 Weeks of Treatment in Patients With Major Depressive Disorder - D0475C00020

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: AZD2066
* Drug: Placebo
* Drug: Duloxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed, written, and dated Informed Consent Documented primary clinical diagnosis of Major Depressive Disorder Exclusion Criteria: Patients with a secondary psychiatric disorder including bipolar disorder, psychotic disorders (i.e. schizophrenia, schizoaffective disorder, depression with psychotic features), GAD and social anxiety disorder Patients whose current episode of depression started less than 4 weeks before enrollment History of inadequate response of antidepressants during current depressive episode

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD2066<br> | Drug: AZD2066<br>* 18 mg once daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Active Comparator: Duloxetine<br>Duloxetine | Drug: Duloxetine<br>* 60 mg once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MADRS Total Score Change From Baseline to Week 6 | Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MADRS Response | A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score. | 6 weeks | 
| MADRS Remission | A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6 | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression