SA4503 8-Week Study in Major Depressive Disorder (MDD) - Full Text View

Sponsored by:	M's Science Corporation
Information provided by:	M's Science Corporation
ClinicalTrials.gov Identifier:	NCT00551109

Purpose

The purpose of this study is to determine the efficacy of SA4503 compared to placebo in the treatment of subjects with major depressive disorder (MDD). Secondary, to evaluate the safety of SA4503 compared to placebo in subjects with MDD.

Condition	Intervention	Phase
Depressive Disorder, Major	Drug: placebo Drug: SA4503 Low Drug: SA4503 High	Phase II

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Safety and Efficacy of Treatment With SA4503, Once Daily for 8 Weeks, in Subjects With Major Depressive Disorder

Further study details as provided by M's Science Corporation:

Primary Outcome Measures:

Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	November 2007
Study Completion Date:	September 2008

Arms	Assigned Interventions
P: Placebo Comparator Placebo	Drug: placebo placebo, oral administration, once daily for 8 weeks
A1: Experimental SA4503	Drug: SA4503 Low Low dose, oral administration, once daily for 8 weeks
A2: Experimental SA4503	Drug: SA4503 High High dose, oral administration, once daily for 8 weeks

Detailed Description:

Further study details as provided by M's Science Corporation:

Eligibility

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

Criteria

Inclusion Criteria:

Male or female between the ages of 18 and 65 (inclusive)
Diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria and a shortened MINI evaluation
HAM-D17 score of >/= 21 and a severity score of at least 2 for Item 1 (depressed mood) at both Screening and Baseline
Current depressive episode of at least 3 months duration, and significant depressed mood and anhedonia in the 4 weeks prior to Screening.

Exclusion Criteria:

Subjects who have received fluoxetine within 1 month prior to Baseline or any other antidepressant within 2 weeks prior to Baseline, or any unlicensed medication within 1 month before Screening
Subjects who require psychotropic medication other than the study medication
Subjects who started psychotherapy within 4 months prior to Screening
Subjects who currently (i.e., in the month prior to Screening) meet DSM-IV criteria for bipolar syndrome or psychotic depression or severe somatoform or eating disorders
Subjects who have a primary diagnosis of anxiety
Subjects who regularly use sleeping medication more than 3 times per week
Subjects who have major psychiatric or neurologic disorders other than MDD
Subjects with depression secondary to stroke, cancer, or other severe medical illness
Subjects who have a history of alcohol or substance dependence(within 1 year prior to Screening)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551109

Locations

Finland

Kuopio, Finland

Jyväskylä, Finland

Tampere, Finland

Turku, Finland

Helsinki, Finland

Sponsors and Collaborators

M's Science Corporation

Investigators

Principal Investigator:

Björn Appelberg, MD, PhD

Helsinki University Central Hospital, Department of Psychiatry

More Information

Responsible Party:	M's Science Corporation ( Kazunori Yoshikawa )
Study ID Numbers:	ME1-1, EudraCT number: 2007-002740-16
Study First Received:	October 29, 2007
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00551109
Health Authority:	Finland: National Agency for Medicines; Lithuania: Bioethics Committee

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
SA 4503

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Nootropic Agents
Pathologic Processes
Disease

Therapeutic Uses
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009