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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Anxious Major Depressive Disorder

Treatments: Drug: AZD2327; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00759395

D0880C00021

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

AZD2327

Experimental group

Description:

AZD2327 3mg BID

Treatment:

Drug: AZD2327

Placebo

Placebo Comparator group

Description:

Placebo BID

Treatment:

Drug: Placebo