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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00759395

Purpose

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

Condition	Intervention	Phase
Anxious Major Depressive Disorder	Drug: AZD2327 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	An Investigation of the Antidepressant Efficacy of a Selective, High, Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Anxiety Depression

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To determine if AZD2327 is effective in the treatment of AMDD in adult men and women as assessed by the Hamilton Rating Scale for Depression [ Time Frame: At screening, pre-treatment, 5 days (4 per day) during in-patient, 4 times during out-patient, and 1 follow up. ] [ Designated as safety issue: No ]
To determine if AZD2327 is effective in the treatment of AMDD in adult men and women as assessed by theHamilton Rating Scale for Anxiety [ Time Frame: At screening, pre-treatment, 5 days (4 per day) during in-patient, 4 times during out-patient, and 1 follow up. ]

Secondary Outcome Measures:

To assess the safety and tolerability of AZD2327 in patients with AMDD as assessed by vital signs, physician exams, labs, ECGs, EEGs, incidence of adverse events and orthostatic challenges. [ Time Frame: To determine if AZD2327 is effective in the treatment of AMDD in adult men and women as assessed by theHamilton Rating Scale for Anxiety ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	January 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Highly selective delta opioid receptor agonist	Drug: AZD2327 Tablet, Oral, QD
2: Placebo Comparator	Drug: Placebo Tablet, Oral, QD

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provision of informed consent prior to any study specific procedures

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759395

Contacts

Contact: Deb Ennis

+1 302 886 5489

debra.ennis@astrazeneca.com

Locations

United States, Maryland
Research Site	Recruiting
Baltimore, Maryland, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Mark Smith, MD	AstraZeneca
Principal Investigator:	Carlos Zarate	National Institute of Mental Health (NIMH)

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Mark A. Smith, MD, Medical Science Director )
Study ID Numbers:	D0880C00021
Study First Received:	September 24, 2008
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00759395 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by AstraZeneca:

Anxious Major Depressive Disorder

Study placed in the following topic categories:

Depression
Mental Disorders
Psychotropic Drugs
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Antidepressive Agents
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Disease
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Pharmacologic Actions
Behavioral Symptoms

Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 11, 2009