NCT00252356

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
468

participants targeted

Target at P50-P75 for phase_3 major-depressive-disorder

Timeline
Completed

Started Sep 2005

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

March 12, 2009

Status Verified

March 1, 2009

Enrollment Period

1.3 years

First QC Date

November 10, 2005

Last Update Submit

March 10, 2009

Conditions

Major Depressive Disorder

Keywords

major depressive disorderdepressionmajor depressive episodeantidepressive agents

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

  • Safety assessments

Interventions

SR58611ADRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Out-patients, 18 year and older.
  • \. Major Depressive Disorder (MDD) with a recurrentMajor Depressive Episode (MDE) according to DSMIV-TR criteria
  • \. Duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration.
  • \. 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis Administrative Office

Laval, Canada

Location

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Amibegron hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 10, 2005

First Posted

November 11, 2005

Study Start

September 1, 2005

Primary Completion

January 1, 2007

Study Completion

May 1, 2007

Last Updated

March 12, 2009

Record last verified: 2009-03

Locations

CA(1)US(1)