A double-blind, multi-center, multinational, randomized withdrawal study evaluating the efficacy and safety of SR58611A (350 mg q12) versus placebo in the prevention of depression relapse up to 1 year in patients with Major Depressive Disorder improved after 12 weeks of open treatment with SR58611A (350 mg q12) - CALYPSO

Conditions: patients with major depressive disorder
MedDRA version: 8.0Level: LLTClassification code 10018105

Registration Number: EUCTR2005-004006-81-FI

Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

1. Out-patients 18 years old or more.
2. Patients diagnosed with Major Depressive Disorder, Recurrent according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition - Text Revision (DSM-IV-TR) criteria and assessed with the M.I.N.I. International Neuropsychiatric Interview (MINI).
3. At least 1 Major Depressive Episode over the past 5 years in addition to the current episode.
4. The duration of the current episode (meeting full DSM-IV-TR criteria) is between 4 weeks and 2 years.
5. With a total score on the Montgomery and Asberg Depression Rating Scale
(MADRS) = 28.
6. Patients have given voluntarily their written informed consent to participate in the
whole maintenance study.
7. Able to comply with the protocol and follow written and verbal instructions.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients at immediate risk for suicidal behavior based on an unstructured clinical interview; or who have, before first study drug intake [at either the screening (V1) or baseline (V2) visits]:
- A score of >5 on the suicidal thoughts item of the MADRS
- Or a current suicide risk score > or equal to 10 from module C of the MINI
2. Patients with a major depressive episode with psychotic features, catatonic features, seasonal pattern or postpartum onset according to MINI at screening.
3. Patients with 3 or more episodes of depression in the last 3 years.
4. The course of the current depressive episode is longer than 2 years.
5. For the current episode, patients failed to respond to an adequate dose of an
antidepressant given for 6 weeks.
6. Patients with mood disorder due to general medical conditions (degenerative
neurological conditions, cerebrovascular disease, endocrine conditions, viral or other
infections).
7. Patients with a lifetime history according to MINI at screening of:
- bipolar disorder or psychotic disorder,
- panic disorder,
- antisocial personality disorder.
8. Patients with a current history according to MINI at screening of:
- alcohol dependence or abuse or substance dependence or abuse in the past
12 months, except nicotine or caffeine dependence,
- eating disorders.
9. Introduction of, or change in intensity of psychotherapy from 3 months prior to
screening.
10. Treatment with a MAO Inhibitor (during one week or more) within 2 weeks prior to screening.
11. Treatment with fluoxetine (during one week or more) within 4 weeks prior to
screening.
12. Chronic use of hypnotics / benzodiazepines. Chronic means more than 2 days per
week during the previous month.
13. Patients who have received Electro-Convulsive Therapy (ECT) for the previous Major Depressive Episode.
14. Patients who received any antipsychotic drugs in the last 4 weeks prior to screening.
15. Patients with severe or unstable concomitant medical conditions (cardiovascular,
neurologic, gastrointestinal, hepatic, renal, endocrinologic, rheumatologic) according
to the investigator's judgment that would impact the assessment of the study drug.
16. History of seizures other than a single childhood febrile seizure.
17. Patients with abnormal thyroid functioning, i.e. TSH blood level at screening out of normal range, unless patients are taking a hormone replacement therapy at a stable dose for at least 3 months prior to baseline.
18. Patients with clinically significant abnormal laboratory value at screening, e.g. ALT or AST > 2 times upper limit of normal range (ULN), hemoglobin < 12g / 100ml for
male and < 11g / 100ml for female, neutrophils < 1500/mm3, platelets < 100 000/mm3, creatinine = 150 µmol/l.
19. Patients with clinically significant ECG findings at screening.
20. Patients with positive results on the urine drug screen at screening.
21. Patients who have taken an investigational drug in the last 3 months prior to screening.
22. Any subject who has previously participated in a SR58611A protocol.
23. Women who are pregnant or breast-feeding; women of childbearing potential who are not using a medically accepted means of contraception when engaging in sexual intercourse: for example intrauterine device, oral contraceptives, implant, hormonal injection, barrier devices or barrier devices with spermicide.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of SR58611A 350 mg q12 compared to placebo in the prevention of relapse of depressive symptoms, in patients with major depressive disorder, over a 24-week to 52-week treatment period.;Secondary Objective: To assess the efficacy and tolerability of SR58611A in patients with major depressive disorder.;Primary end point(s): Time to relapse during segment C. Relapse of depressive disorder is defined as any of the following after randomization:<br>•MADRS = 17 confirmed at a subsequent visit 2 weeks later unless the patient drops<br>out, or<br>• Any drop-out for lack of efficacy (according to investigator’s decision based on his/her knowledge of the patient), or<br>• Prescription/use of alternative or additional treatments (pharmacological or nonpharmacological)for relief of psychiatric symptoms, or<br>• Any suicide attempt / suicide.

Secondary Outcome Measures