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

December 17, 2008 updated by: M's Science Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
      • Jyväskylä, Finland
      • Kuopio, Finland
      • Tampere, Finland
      • Turku, Finland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: P
Placebo
Drug: placebo
placebo, oral administration, once daily for 8 weeks
Experimental: A1
SA4503
Drug: SA4503 Low
Low dose, oral administration, once daily for 8 weeks
Experimental: A2
SA4503
Drug: SA4503 High
High dose, oral administration, once daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M's Science Corporation

Investigators

  • Principal Investigator: Björn Appelberg, MD, PhD, Helsinki University Central Hospital, Department of Psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

October 29, 2007

First Submitted That Met QC Criteria

October 29, 2007

First Posted (Estimate)

October 30, 2007

Study Record Updates

Last Update Posted (Estimate)

December 18, 2008

Last Update Submitted That Met QC Criteria

December 17, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ME1-1
  • EudraCT number: 2007-002740-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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