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

Primary Purpose

Depressive Disorder, Major

Status

Completed

Phase

Phase 2

Locations

Finland

Study Type

Interventional

Intervention

placebo

SA4503 Low

SA4503 High

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Placebo

SA4503

Outcomes

Primary Outcome Measures

Montgomery-Åsberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Full Information

NCT ID

NCT00551109

First Posted

October 29, 2007

Last Updated

December 17, 2008

Sponsor

M's Science Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00551109

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

M's Science Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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:

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Major

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Arm Type

Experimental

Arm Description

SA4503

Arm Title

Arm Type

Experimental

Arm Description

SA4503

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo, oral administration, once daily for 8 weeks

Intervention Type

Drug

Intervention Name(s)

SA4503 Low

Intervention Description

Low dose, oral administration, once daily for 8 weeks

Intervention Type

Drug

Intervention Name(s)

SA4503 High

Intervention Description

High dose, oral administration, once daily for 8 weeks

Primary Outcome Measure Information:

Title

Montgomery-Åsberg Depression Rating Scale (MADRS)

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Björn Appelberg, MD, PhD

Organizational Affiliation

Helsinki University Central Hospital, Department of Psychiatry

Official's Role

Principal Investigator

Facility Information:

City

Helsinki

Country

Finland

City

Jyväskylä

Country

Finland

City

Kuopio

Country

Finland

City

Tampere

Country

Finland

City

Turku

Country

Finland

12. IPD Sharing Statement

Learn more about this trial

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

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