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

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551109
• Other study ID #: ME1-1
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2007
• Last updated: December 17, 2008
• Start date: November 2007
• Est. completion date: September 2008

Study information

• Verified date: December 2008
• Source: M's Science Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyLithuania: Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
M's Science Corporation

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Åsberg Depression Rating Scale (MADRS)		8 weeks	Yes