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

NCT ID: NCT00551109

Last Updated: 2008-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-09-30

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:

Conditions

Depressive Disorder, Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

P

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo, oral administration, once daily for 8 weeks

A1

SA4503

Group Type: EXPERIMENTAL

SA4503 Low

Intervention Type: DRUG

Low dose, oral administration, once daily for 8 weeks

A2

SA4503

Group Type: EXPERIMENTAL

SA4503 High

Intervention Type: DRUG

High dose, oral administration, once daily for 8 weeks

Interventions

placebo

placebo, oral administration, once daily for 8 weeks

Intervention Type: DRUG

SA4503 Low

Low dose, oral administration, once daily for 8 weeks

Intervention Type: DRUG

SA4503 High

High dose, oral administration, once daily for 8 weeks

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M's Science Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

M's Science Corporation

Principal Investigators

Björn Appelberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital, Department of Psychiatry

Locations

Helsinki, , Finland

Jyväskylä, , Finland

Kuopio, , Finland

Tampere, , Finland

Turku, , Finland

Countries

Finland

Other Identifiers

EudraCT number: 2007-002740-16

Identifier Type: -

Identifier Source: secondary_id

ME1-1

Identifier Type: -

Identifier Source: org_study_id