NCT00825019

Brief Summary

Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (MDD). Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
306

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_3

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, 2003

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

1.1 years

First QC Date

January 16, 2009

Last Update Submit

March 24, 2009

Conditions

Major Depressive Disorders

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

  • change from baseline of the total score of the HAM-D 17 items

    6 weeks

Secondary Outcomes (7)

  • HAM-D subscores, HAMD responders and remitters, HAM-A total score and subscores

    6 weeks

  • Montgomery-Asberg Depression Rating Scale (MADRS) total score

    6 weeks

  • clinical global impression (CGI) severity and improvement scores

    6 weeks

  • patient global impression (PGI) improvement score

    6 weeks

  • social and occupational functioning assessment scale (SOFAS) score

    6 weeks

  • +2 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL
Drug: amibegron (SR58611A)

2

PLACEBO COMPARATOR
Drug: placebo

3

ACTIVE COMPARATOR

paroxetine

Drug: paroxetine

Interventions

amibegron (SR58611A)DRUG

oral administration of 2x 700 mg/day in 12h intervals

1
placeboDRUG

oral administration in 12h intervals

2
paroxetineDRUG

oral administration of 20 mg/day

3

Eligibility Criteria

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

You may qualify if:

  • patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV)
  • patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months.
  • the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration.

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 hydrochlorideParoxetine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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

January 16, 2009

First Posted

January 19, 2009

Study Start

September 1, 2003

Primary Completion

October 1, 2004

Study Completion

December 1, 2004

Last Updated

March 25, 2009

Record last verified: 2009-03

Locations

US(1)