An Eight-Week Study to Evaluate the Efficacy and Safety o... | NCT00319709

Studies
An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Depression

NCT00319709

Sponsor

Sanofi

Status

Completed

Last Update Posted

Mar 12, 2009Estimated

Enrollment

288Actual

Phase

Phase 3

Conditions

Depressive Disorder

Interventions

SR58611A

Countries

Bulgaria
Finland
Romania
Serbia
Slovakia

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

ID	Type	Description	Link
EudraCT 2005-005597-67

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

Apr 2006

Primary Completion Date

Apr 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Apr 28, 2006

First Submission Date that Met QC Criteria

Apr 28, 2006

First Posted Date

Apr 27, 2006Estimated

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 10, 2009

Last Update Posted Date

Mar 12, 2009Estimated

Description Module

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of SR58611A in elderly patients with depression.The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in elderly patients with depression. The secondary objectives are to evaluate the safety of SR58611A and to evaluate the efficacy of SR58611A on disability and quality of life in elderly patients with depression.

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

288Actual

Name	Type	Description	Arm Group Labels	Other Names
SR58611A	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score.

Secondary Outcomes

Measure	Description	Time Frame
The main secondary outcomes are the changes from baseline to Day 56 of treatment in the HAM-D depressed mood item, the Montgomery Asberg Depression Rating Scale total, and the Clinical Global Impression Severity of Illness scores.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatients or inpatients
Major Depressive Disorder (MDD) with a recurrent Major Depressive Episode (MDE) according to DSM IV-TR criteria.
MADRS score equal of above 22.

Exclusion Criteria:

Patients with a current significant risk of suicide in the investigator's clinical judgment.
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 according to MINI at screening of:bipolar disorder, psychotic disorder, antisocial personality disorder.
Patients with a current history according to MINI at screening of anxiety disorders, alcohol dependence or abuse or substance dependence or abuse
Patients with severe or unstable concomitant medical conditions.
History of seizures other than a single childhood febrile seizure.
Patients with abnormal thyroid functioning.
Patients with clinically significant ECG findings at screening.
Patients who have taken an investigational drug in the last 3 months prior to screening.
Any subject who has previously participated in a SR58611A protocol.
Patients with Mini-Mental State Examination (MMSE) score < 25 at screening.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

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

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D003866	Depressive Disorder
D003863	Depression