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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00759395

First received: September 24, 2008

Last updated: October 10, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 24, 2008

Last Updated Date

October 10, 2012

Start Date ^ICMJE

January 2009

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hamilton Rating Scale for Depression (HAM-D) Total Score. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
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.
Hamilton Rating Scale for Anxiety (HAM-A) Total Score. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
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.

Original Primary Outcome Measures ^ICMJE

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. ]

Change History

Complete list of historical versions of study NCT00759395 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D). [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
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.
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score. [ Time Frame: Randomization to week 4 ] [ Designated as safety issue: No ]
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.
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score. [ Time Frame: Randomization to week 4 ] [ Designated as safety issue: No ]
Hamilton Rating Scale for Anxiety (HAM-A) response is defined as a >= 50% reduction from randomization (baseline) in 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.

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Investigation of the Antidepressant Efficacy of a Selective, High, Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Anxious Major Depressive Disorder

Intervention ^ICMJE

Drug: AZD2327
Tablet, Oral, Daily
Drug: Placebo
Tablet, Oral, Daily

Study Arm (s)

Experimental: AZD2327
AZD2327 3mg BID

Intervention: Drug: AZD2327
Placebo Comparator: Placebo
Placebo BID

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00759395

Other Study ID Numbers ^ICMJE

D0880C00021

Has Data Monitoring Committee

Yes

Responsible Party

AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

AstraZeneca

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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