Clinical trial NCT00319709: An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Depression
Official title: An Eight-Week, Double-Blind Placebo Controlled, Multicenter Study Evaluating the Efficacy, Safety, Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Elderly Patients With Major Depressive Disorder (MDD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder
Keywords: depression
antidepressive agents
controlled clinical trial
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 288
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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: 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:
Locations:
city: Sofia
country: Bulgaria
facility: Sanofi-Aventis Administrative Office
city: Helsinki
country: Finland
facility: Sanofi-Aventis Administrative Office
city: Bucuresti
country: Romania
facility: Sanofi-Aventis Administrative Office
city: Belgrade
country: Serbia
facility: Sanofi-Aventis Administrative Office
city: Bratislava
country: Slovakia
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: