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

NCT00319709 | Completed Phase 3

• 2 other identifiers: EFC4846EudraCT 2005-005597-67
• Study Type: interventional
• Target: 288
• Locations: 5 countries
• Sites: 5

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.

Conditions

Depressive Disorder

Keywords

depression; antidepressive agents; controlled clinical trial

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• 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.

Interventions

SR58611A DRUG

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (5)

Sanofi-Aventis Administrative Office

Sofia, Bulgaria

Location

Sanofi-Aventis Administrative Office

Helsinki, Finland

Location

Sanofi-Aventis Administrative Office

Bucharest, Romania

Location

Sanofi-Aventis Administrative Office

Belgrade, Serbia

Location

Sanofi-Aventis Administrative Office

Bratislava, Slovakia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder; Depression

Interventions

Amibegron hydrochloride

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

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: April 28, 2006
• First Posted: April 27, 2006
• Study Start: April 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: August 1, 2007
• Last Updated: March 12, 2009

Record last verified: 2009-03

Locations

RO (1); BU (1); SE (1); SL (1); FI (1)