Efficacy and Safety of SR58611 Compared to Placebo and Pa... | NCT00825058

Studies
Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

NCT00825058

Sponsor

Sanofi

Status

Completed

Last Update Posted

Mar 25, 2009Estimated

Enrollment

317Actual

Phase

Phase 3

Conditions

Major Depressive Disorders

Interventions

amibegron (SR58611A)
placebo
paroxetine

Countries

Bulgaria
Croatia
Czechia
Estonia
France
Montenegro
Netherlands
Serbia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

May 2004Actual

Completion Date

Oct 2004Actual

First Submitted Date

Jan 16, 2009

First Submission Date that Met QC Criteria

Jan 16, 2009

First Posted Date

Jan 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2009

Last Update Posted Date

Mar 25, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Primary objective :

To demonstrate the antidepressant efficacy on the Hamilton Depression Rating Scale of SR58611A 700mg/day compared with placebo in the treatment of patients with a recurrent major depressive episode.

Secondary objectives:

To assess the safety profile of SR58611A 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

317Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Drug: amibegron (SR58611A)
2	Placebo Comparator	Drug: placebo
3	Active Comparator	Drug: paroxetine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
amibegron (SR58611A)	Drug	oral administration 2 X 350mg/day at 12 hours intervals	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change from baseline of the total score of the HAM-D 17 items.		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
HAM-D subscores		6 weeks
HAM-D responders and remitters		6 weeks
HAM-A total score and subscores

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ICD CSD	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Sofia			Bulgaria
Sanofi-Aventis Administrative Office

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C076252	amibegron
C000722902	Amibegron hydrochloride
D017374	Paroxetine

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided