Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— ORION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252356
• Other study ID #: EFC5041
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2005
• Last updated: March 10, 2009
• Start date: September 2005
• Est. completion date: May 2007

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: May 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• SR58611A

Locations

Country	Name	City	State
Canada	Sanofi-Aventis Administrative Office	Laval
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	17-item Hamilton Depression Rating Scale (HAM-D) total score
Secondary	Change from baseline in Clinical Global Impression (CGI) and MADRS Severity of Illness score
Secondary	Safety assessments

External Links

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