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

M's Science

Status and phase: Completed; Phase 2

Conditions: Depressive Disorder, Major

Treatments: Drug: SA4503 Low; Drug: SA4503 High; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00551109

EudraCT number: 2007-002740-16

ME1-1

Details and patient eligibility

About

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.

Full description

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

P

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo

A1

Experimental group

Description:

SA4503

Treatment:

Drug: SA4503 Low

A2

Experimental group

Description:

SA4503

Treatment:

Drug: SA4503 High