Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2007-11-30
2008-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
P
Placebo
placebo
placebo, oral administration, once daily for 8 weeks
A1
SA4503
SA4503 Low
Low dose, oral administration, once daily for 8 weeks
A2
SA4503
SA4503 High
High dose, oral administration, once daily for 8 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
placebo
placebo, oral administration, once daily for 8 weeks
SA4503 Low
Low dose, oral administration, once daily for 8 weeks
SA4503 High
High dose, oral administration, once daily for 8 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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)
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
M's Science Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
M's Science Corporation
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Björn Appelberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital, Department of Psychiatry
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Helsinki, , Finland
Jyväskylä, , Finland
Kuopio, , Finland
Tampere, , Finland
Turku, , Finland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EudraCT number: 2007-002740-16
Identifier Type: -
Identifier Source: secondary_id
ME1-1
Identifier Type: -
Identifier Source: org_study_id