E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major Depressive Disorder (MDD) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018105 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of a fixed dose of SR58611A (350 mg q12) compared to placebo in elderly patients with Major Depressive Disorder (MDD). |
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E.2.2 | Secondary objectives of the trial |
To evaluate the tolerability and safety of SR58611A in patients with MDD. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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). |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
17-item Hamilton Depression Rating Scale (HAM-D) total score. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |