Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (ORION)

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00252356

First received: November 10, 2005

Last updated: March 10, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

November 10, 2005

Last Updated Date

March 10, 2009

Start Date ^ICMJE

September 2005

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

17-item Hamilton Depression Rating Scale (HAM-D) total score

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00252356 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in Clinical Global Impression (CGI) and MADRS Severity of Illness score
Safety assessments

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder

Official Title ^ICMJE

An Eight-Week, Double-Blind, Placebo Controlled, Multicenter Study With Escitalopram (10 mg qd) as Positive Control, Evaluating the Efficacy, Safety, Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Outpatients With MDD

Brief Summary

To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive control. The study is a multicenter, US and Canadian, randomized, double-blind, 3-parallel-group, placebo- and escitalopram-controlled, Phase III study consisting of four segments (A, B, C and D). Segment A is a 1-week, placebo, single-blind period. Segment B is an 8-week, double-blind period. Segment C is an optional 18-week double-blind extension period. Segment D is a 1-week safety follow-up period after study drug discontinuation or early termination (during Segment B or C).

Detailed Description

To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive control. The present study is an 8-week, double-blind, placebo- and escitalopram-controlled, randomized, parallel-group study. A 1-week, placebo, single-blind period precedes the 8-week randomized treatment period and an optional 18-week, double-blind extension period follows the randomized treatment period. A Safety Follow up Visit is scheduled 1 week after the acute and extension period, or early termination. Escitalopram, a selective serotonin reuptake inhibitor (SSRI), an approved treatment for MDD, is chosen as a positive control agent in this study. The dose of 10 mg is within the approved dose range with no need for dose adjustment in elderly patients. This trial is designed to formally compare the efficacy, safety, and tolerability of SR58611A to placebo. Escitalopram is used as a positive control.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Major Depressive Disorder

Intervention ^ICMJE

Drug: SR58611A

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

468

Completion Date

May 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Main inclusion criteria:

1. Out-patients, 18 year and older.
2. Major Depressive Disorder (MDD) with a recurrentMajor Depressive Episode (MDE) according to DSMIV-TR criteria
3. Duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration.
4. Patients have been treated or hospitalized for aprevious episode, or a previous episode requiredantidepressant treatment(s) at the recommended doselevel for a continuous total duration of at least 2months.

Exclusion Criteria:

Main exclusion criteria:

1. Patients at immediate risk for suicidal behavior
2. Patients with a MDE with psychotic features, catatonic features, seasonal pattern or postpartum onset
3. The duration of the current depressive episode is greater than 2 years
4. Patients whose current depressive episode is secondary to a general medical condition
5. Patients with a lifetime history of (1) bipolar disorder, (2) psychotic disorder, (3) antisocial personality disorder
6. Patients who have received non-pharmacologic, somatic treatments for psychiatric disease
7. Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00252356

Other Study ID Numbers ^ICMJE

EFC5041

Has Data Monitoring Committee

Not Provided

Responsible Party

ICD Study Director, sanofi-aventis

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi

Information Provided By

Sanofi

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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