An eight-week, double-blind placebo controlled, multicenter study evaluating theefficacy, safety, tolerability of a fixed dose of SR58611A (350 mg q12) in elderly patients with Major Depressive Disorder (MDD) - ZEPHIR

Conditions: Major Depressive Disorder (MDD)
MedDRA version: 8.0Level: LLTClassification code 10018105

Registration Number: EUCTR2005-005597-67-FI

Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 280

Inclusion Criteria

For inclusion into Segment A of the study, patients must fulfill the following criteria:
1. Out- or in-patients 65 years old or more
2. Patients suffering from Major Depressive Disorder (MDD), and presenting a recurrent Major Depressive Episode (MDE) according to Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria (DSM-IV-TR) and assessed with the Mini International Neuropsychiatric Interview (MINI).
3. With a total score on the Montgomery and Asberg Depression Rating Scale
(MADRS) = 22.
4. The duration of the current episode is at least of 6 weeks unless the severity of
symptoms justifies shorter duration.
5. Patients have been hospitalized for the treatment of a previous episode, or a previous episode required one or several antidepressant treatment(s) at the recommended dose level for a continuous total duration of at least 2 months.
6. Patients have given voluntarily their written informed consent to participate in the
study.
7. Able to comply with the protocol and follow written and verbal instructions.

For inclusion into Segment B of the study, patients must fulfill the following criteria:
8. All Segment A inclusion criteria.
9. Complete a minimum of 3 and a maximum of 9 days of treatment in Segment A.
10. Not placebo responder” (i.e., improvement = 20% on MADRS total score between
Visit 1 and Visit 2).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Psychiatric
1. Patients with a current significant risk of suicide in the investigator’s clinical judgment or who have, before randomization [at either the screening (V1) or baseline (V2) visits]:
-A score of >5 on the suicidal thoughts item of the MADRS (item 10)
-Or a score of 4 on the suicide item of the Hamilton Depression Rating Scale
-Or a current suicide risk score >10 on module C of the MINI
2. Patients with a MDE with psychotic features, catatonic features, seasonal pattern
(DSM-IV criteria) assessed with MINI or DSM-IV.
3. The duration of the current depressive episode is greater than 2 years.
4. Patients whose current depressive episode is secondary to a general medical conditions (degenerative neurological conditions, cerebrovascular disease, endocrine conditions, viral or other infections).
5. Patients with a lifetime history according to MINI at screening of:
- bipolar disorder,
- psychotic disorder,
- antisocial personality disorder.
6. Patients with a current history according to MINI at screening of:
- general anxiety disorder, panic disorder, agoraphobia, social phobia, obsessive compulsive disorder, post-traumatic stress disorder,
- alcohol dependence or abuse or substance dependence or abuse in the past 12
months, except nicotine or caffeine dependence,
- eating disorder (anorexia nervosa or bulimia nervosa).
7. Patients who have used the following prior to screening:
- Treatment with a MAO Inhibitor within two weeks,
- Treatment with fluoxetine within four weeks,
- Treatment with any antipsychotic drugs in the last four weeks,
- Use of benzodiazepines on a chronic basis one week prior to screening,
- Use of any other antidepressant, anxiolytic, sedative-hypnotic, mood-stabilizer
(lithium, anticonvulsants), or other psychotropic drug one week prior to screening
except permitted concomitant medications as defined in Section 8.9.2.
8. Patients who have received Electro-Convulsive Therapy (ECT) within the six previous months.
9. Introduction of, or change in intensity of psychotherapy from 3 months prior to
screening.

General and medical
10. Patients with severe or unstable concomitant medical conditions (cardiovascular,
neurologic, gastrointestinal, hepatic, renal, endocrinologic, rheumatologic) according
to the investigator's judgment.
11. History of seizures other than a single childhood febrile seizure.
12. Patients with abnormal thyroid functioning, i.e. TSH blood level at screening out ofnormal range, unless patients are taking a hormone replacement therapy at a stable dose for at least 3 months prior to baseline.
13. Patients with clinically significant ECG findings at screening.
14. Patients who have taken an investigational drug in the last 3 months prior to screening.
15. Any subject who has previously participated in a SR58611A protocol.
16. Patients with Mini-Mental State Examination (MMSE) score < 21 at screening.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of a fixed dose of SR58611A (350 mg q12) compared to placebo in elderly patients with Major Depressive Disorder (MDD).;Secondary Objective: To evaluate the tolerability and safety of SR58611A in patients with MDD.;Primary end point(s): 17-item Hamilton Depression Rating Scale (HAM-D) total score.

Secondary Outcome Measures

Name	Time	Method

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