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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.
 
ClinicalTrials.gov Identifier: NCT00551109
Recruitment Status : Completed
First Posted : October 30, 2007
Last Update Posted : December 18, 2008
Sponsor:
Information provided by:
M's Science Corporation

Tracking Information
First Submitted Date  ICMJE October 29, 2007
First Posted Date  ICMJE October 30, 2007
Last Update Posted Date December 18, 2008
Study Start Date  ICMJE November 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2007)
Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00551109 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SA4503 8-Week Study in Major Depressive Disorder (MDD)
Official Title  ICMJE 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
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.
Detailed Description Further study details as provided by M's Science Corporation:
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • Drug: placebo
    placebo, oral administration, once daily for 8 weeks
  • Drug: SA4503 Low
    Low dose, oral administration, once daily for 8 weeks
  • Drug: SA4503 High
    High dose, oral administration, once daily for 8 weeks
Study Arms  ICMJE
  • Placebo Comparator: P
    Placebo
    Intervention: Drug: placebo
  • Experimental: A1
    SA4503
    Intervention: Drug: SA4503 Low
  • Experimental: A2
    SA4503
    Intervention: Drug: SA4503 High
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
Estimated Enrollment  ICMJE
 (submitted: October 29, 2007)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00551109
Other Study ID Numbers  ICMJE ME1-1
EudraCT number: 2007-002740-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kazunori Yoshikawa, M's Science Corporation
Study Sponsor  ICMJE M's Science Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Björn Appelberg, MD, PhD Helsinki University Central Hospital, Department of Psychiatry
PRS Account M's Science Corporation
Verification Date December 2008

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