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

Phase 2

Completed

• Conditions: Anxious Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: AZD2327

• Registration Number: NCT00759395
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Study Start: 2009-01
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-10
• Results First Submitted: 2012-10-10
• Results First Submitted QC: 2012-10-10
• Last Update Submitted: 2012-10-10
• Results First Posted: 2012-11-08
• Last Update Posted: 2012-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Provision of informed consent prior to any study specific procedures
• Diagnosis of major depressive disorder without psychotic features (MDD)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo BID
AZD2327	AZD2327	AZD2327 3mg BID

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression (HAM-D) Total Score.	Week 4	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.
Hamilton Rating Scale for Anxiety (HAM-A) Total Score.	Week 4	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.

Secondary Outcome Measures

Name	Time	Method
Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).	Week 4	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.
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.	Randomization to week 4	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.
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score.	Randomization to week 4	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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Baltimore, Maryland, United States