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

AstraZeneca22 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Anxious Major Depressive Disorder

Interventions

AZD2327DRUG

Tablet, Oral, Daily

PlaceboDRUG

Tablet, Oral, Daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Week 4

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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