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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00551109
Recruitment Status : Completed
First Posted : October 30, 2007
Last Update Posted : December 18, 2008
Information provided by:
M's Science Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: placebo Drug: SA4503 Low Drug: SA4503 High Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2007
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: P
Drug: placebo
placebo, oral administration, once daily for 8 weeks

Experimental: A1
Drug: SA4503 Low
Low dose, oral administration, once daily for 8 weeks

Experimental: A2
Drug: SA4503 High
High dose, oral administration, once daily for 8 weeks

Primary Outcome Measures :
  1. Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00551109

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Helsinki, Finland
Jyväskylä, Finland
Kuopio, Finland
Tampere, Finland
Turku, Finland
Sponsors and Collaborators
M's Science Corporation
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Principal Investigator: Björn Appelberg, MD, PhD Helsinki University Central Hospital, Department of Psychiatry

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Responsible Party: Kazunori Yoshikawa, M's Science Corporation Identifier: NCT00551109     History of Changes
Other Study ID Numbers: ME1-1
EudraCT number: 2007-002740-16
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: December 18, 2008
Last Verified: December 2008
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
SA 4503
Nootropic Agents