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

Sponsor:	AstraZeneca
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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 ]

Enrollment:	29
Study Start Date:	January 2009
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

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

Locations

United States, Maryland
Research Site
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
ClinicalTrials.gov Identifier:	NCT00759395 History of Changes
Obsolete Identifiers:	NCT00738270
Other Study ID Numbers:	D0880C00021
Study First Received:	September 24, 2008
Last Updated:	October 13, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by AstraZeneca:

Anxious Major Depressive Disorder

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012