Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)

Study Overview
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Brief Summary
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This study will determine if a highly selective enkephalinergic receptor modulator is effective in the treatment of anxious major depressive disorder.

Official Title
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An Investigation of the Antidepressant Efficacy of a Selective, High, Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder

Conditions
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Anxious Major Depressive Disorder

Intervention / Treatment
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* Drug: AZD2327
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study specific procedures Diagnosis of major depressive disorder without psychotic features (MDD) Exclusion Criteria: A history of substance or alcohol abuse within the past 6 months or dependence within 1 year of enrollment as defined by DSM-IV criteria. Women that are pregnant or lactating History of pancreatitis

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD2327<br>AZD2327 3mg BID | Drug: AZD2327<br>* Tablet, Oral, Daily<br>|
| Placebo Comparator: Placebo<br>Placebo BID | Drug: Placebo<br>* Tablet, Oral, Daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression (HAM-D) Total Score. | Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression. | Week 4 | 
| Hamilton Rating Scale for Anxiety (HAM-A) Total Score. | The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D). | Psychic anxiety item of the Hamilton Rating Scale for Depression (HAM-D) (item 10, 0-4 units), 0 is considered the best outcome. Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression. | Week 4 | 
| The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score. | Hamilton Rating Scale for Depression (HAM-D) response is defined as a >= 50% reduction from randomization (baseline) in HAM-D total score. Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression. | Randomization to week 4 | 
| The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score. | Hamilton Rating Scale for Anxiety (HAM-A) response is defined as a >= 50% reduction from randomization (baseline) in HAM-A total score. The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome. | Randomization to week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxious Major Depressive Disorder