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Sponsored by: |
M's Science Corporation |
---|---|
Information provided by: | M's Science Corporation |
ClinicalTrials.gov Identifier: | NCT00551109 |
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 |
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 |
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
|
Further study details as provided by M's Science Corporation:
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Finland | |
Kuopio, Finland | |
Jyväskylä, Finland | |
Tampere, Finland | |
Turku, Finland | |
Helsinki, Finland |
Principal Investigator: | Björn Appelberg, MD, PhD | Helsinki University Central Hospital, Department of Psychiatry |
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 |
Depression Mental Disorders Mood Disorders SA 4503 |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
Nootropic Agents Pathologic Processes Disease |
Therapeutic Uses Central Nervous System Agents Pharmacologic Actions |