MedDataX Logo

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

NCT ID: NCT00759395

Last Updated: 2012-11-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxious Major Depressive Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Anxious Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AZD2327

AZD2327 3mg BID

Group Type EXPERIMENTAL

AZD2327

Intervention Type DRUG

Tablet, Oral, Daily

Placebo

Placebo BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet, Oral, Daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD2327

Tablet, Oral, Daily

Intervention Type DRUG

Placebo

Tablet, Oral, Daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mark Smith, MD

Role: STUDY_DIRECTOR

AstraZeneca

Carlos Zarate

Role: PRINCIPAL_INVESTIGATOR

National Institute of Mental Health (NIMH)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Baltimore, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Richards EM, Mathews DC, Luckenbaugh DA, Ionescu DF, Machado-Vieira R, Niciu MJ, Duncan WC, Nolan NM, Franco-Chaves JA, Hudzik T, Maciag C, Li S, Cross A, Smith MA, Zarate CA Jr. A randomized, placebo-controlled pilot trial of the delta opioid receptor agonist AZD2327 in anxious depression. Psychopharmacology (Berl). 2016 Mar;233(6):1119-30. doi: 10.1007/s00213-015-4195-4. Epub 2016 Jan 4.

Reference Type DERIVED
PMID: 26728893 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D0880C00021

Identifier Type: -

Identifier Source: org_study_id

NCT00738270

Identifier Type: -

Identifier Source: nct_alias