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

NCT00551109 | Completed Phase 2 DMC

• 2 other identifiers: ME1-1EudraCT number: 2007-002740-16
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  8 weeks

Study Arms (3)

P

PLACEBO COMPARATOR

Placebo

Drug: placebo

A1

EXPERIMENTAL

SA4503

Drug: SA4503 Low

A2

EXPERIMENTAL

SA4503

Drug: SA4503 High

Interventions

placebo DRUG

placebo, oral administration, once daily for 8 weeks

P

SA4503 Low DRUG

Low dose, oral administration, once daily for 8 weeks

A1

SA4503 High DRUG

High dose, oral administration, once daily for 8 weeks

A2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• M's Science Corporation: lead

Study Sites (5)

Unknown Facility

Helsinki, Finland

Location

Unknown Facility

Jyväskylä, Finland

Location

Unknown Facility

Kuopio, Finland

Location

Unknown Facility

Tampere, Finland

Location

Unknown Facility

Turku, Finland

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Björn Appelberg, MD, PhD

  Helsinki University Central Hospital, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: October 30, 2007
• Study Start: November 1, 2007
• Study Completion: September 1, 2008
• Last Updated: December 18, 2008

Record last verified: 2008-12

Locations

FI (5)