NCT00385307

Brief Summary

To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
680

participants targeted

Target at P75+ for phase_3 major-depressive-disorder

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_3 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

1.2 years

First QC Date

October 6, 2006

Last Update Submit

March 24, 2009

Conditions

Major Depressive Disorder

Keywords

DepressionClinical TrialsMajor Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in total score of a depression rating scale at 8 weeks

Secondary Outcomes (1)

  • Safety assessments

Interventions

amibegron (SR58611A)DRUG

Eligibility Criteria

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

You may qualify if:

  • Patient with Major Depressive Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR
  • Patient meets criteria for a recurrent Major Depressive Episode (MDE)
  • Patient meets severity assessments of depression specified by the study

You may not qualify if:

  • Patient is at immediate risk for suicidal behavior
  • Patient is with a unstable medical condition
  • Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
  • Patient has taken concomitant treatment that may interfere with valid collection or interpretation of study data
  • Patient has been treated with non-pharmacologic therapy intended to treat depression in the past 6 months
  • Patient has been treated with paroxetine (Paxil) within the previous 6 months
  • Patient is pregnant or breastfeeding, or likely to become pregnant during the course of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

amibegronAmibegron 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

October 6, 2006

First Posted

October 9, 2006

Study Start

September 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

March 25, 2009

Record last verified: 2009-03

Locations

US(1)