SA4503 8-Week Study in Major Depressive Disorder (MDD)
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
placebo
SA4503 Low
SA4503 High
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major
Eligibility 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
P
A1
A2
Arm Description
Placebo
SA4503
SA4503
Outcomes
Primary Outcome Measures
Montgomery-Åsberg Depression Rating Scale (MADRS)
Secondary Outcome Measures
Full Information
NCT ID
NCT00551109
First Posted
October 29, 2007
Last Updated
December 17, 2008
Sponsor
M's Science Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00551109
Brief Title
SA4503 8-Week Study in Major Depressive Disorder (MDD)
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 Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
M's Science Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
P
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
A1
Arm Type
Experimental
Arm Description
SA4503
Arm Title
A2
Arm Type
Experimental
Arm Description
SA4503
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo, oral administration, once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
SA4503 Low
Intervention Description
Low dose, oral administration, once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
SA4503 High
Intervention Description
High dose, oral administration, once daily for 8 weeks
Primary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Björn Appelberg, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital, Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
City
Helsinki
Country
Finland
City
Jyväskylä
Country
Finland
City
Kuopio
Country
Finland
City
Tampere
Country
Finland
City
Turku
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
SA4503 8-Week Study in Major Depressive Disorder (MDD)
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