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

This study has been completed.
Sponsor:
Information provided by:
M's Science Corporation
ClinicalTrials.gov Identifier:
NCT00551109
First received: October 29, 2007
Last updated: December 17, 2008
Last verified: December 2008
History of Changes
  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 2

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: 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

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

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
Placebo Comparator: P
Placebo
 Drug: placebo
placebo, oral administration, once daily for 8 weeks
Experimental: A1
SA4503
 Drug: SA4503 Low
Low dose, oral administration, once daily for 8 weeks
Experimental: A2
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
Helsinki, Finland
Jyväskylä, Finland
Kuopio, Finland
Tampere, Finland
Turku, Finland
Sponsors and Collaborators
M's Science Corporation
Investigators
Principal Investigator: Björn Appelberg, MD, PhD Helsinki University Central Hospital, Department of Psychiatry
  More Information

No publications provided

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

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
 SA 4503
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013