E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major Depressive Disorder |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025454 |
E.1.2 | Term | Major depressive disorder, recurrent episode |
E.1.2 | System Organ Class | 100000004873 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025453 |
E.1.2 | Term | Major depressive disorder NOS |
E.1.2 | System Organ Class | 100000004873 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067465 |
E.1.2 | Term | Major depressive disorder aggravated |
E.1.2 | System Organ Class | 100000004873 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053708 |
E.1.2 | Term | Major depressive disorder with melancholic features |
E.1.2 | System Organ Class | 100000004873 |
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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, safety, and tolerability of vilazodone relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD). |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Criteria to be Assessed at Visit 1 (Screening): 1. Provide written informed consent before the initiation of any study-specific procedures. 2. Be a male or female outpatient, 18 to 70 years of age, inclusive. 3. Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD (American Psychiatric Association, 2000), confirmed with the Mini International Neuropsychiatric Interview (MINI), with an ongoing major depressive episode of ≥ 8 weeks and ≤ 18 months in duration at Visit 1 (Screening). Patients must have a minimum of 3 lifetime episodes of MDD, (including the current episode) and 2 episodes within the past 5 years (including the current episode). 4. Have a score of ≥ 26 on the Montgomery-Åsberg Depression Rating Scale (MÅDRS). 5. Have a body mass index between 18 and 40, inclusive. 6. If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test. 7. Have normal physical examination findings, clinical laboratory test results, and electrocardiogram (ECG) results from Screening (Visit 1), or abnormal results that are judged not clinically significant by the Investigator and documented as such in the eCRF.
Criteria to be Assessed at Visit 2 (Baseline): 8. Have a score of ≥ 26 on the MÅDRS. 9. Negative results for illegal or prohibited substances or alcohol on a urine drug screen.
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E.4 | Principal exclusion criteria |
•Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control •Patients with a history of meeting DSM-IV-TR criteria for:
◦any manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode; ◦any depressive episode with psychotic or catatonic features; ◦panic disorder with or without agoraphobia; ◦obsessive-compulsive disorder; ◦Schizophrenia, schizoaffective, or other psychotic disorder; ◦bulimia or anorexia nervosa within the past 5 years; ◦presence of borderline personality disorder or antisocial personality disorder; mental retardation, dementia, amnesia, or other cognitive disorders •Patients who are considered a suicide risk
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to first relapse during the double-blind treatment phase, defined as the number of days from the randomization date to the relapse date. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Relapse during the DBP will be defined as meeting any one or more of the following criteria: • MÅDRS score of ≥ 18 and MDE per MDD checklist • MÅDRS total score ≥ 18 at 2 consecutive visits (Second visit to be scheduled in 7 - 14 day period after the first visit). • Discontinuation for insufficient therapeutic response during the DBP as indicated in the termination page of the eCRF.
The evaluation of endpoint is therefore ongoing during the conduct of the study. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | No |
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.8.2.4 | Number of treatment arms in the trial | 3 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
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 | No |
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 |
Bulgaria |
Romania |
Czech Republic |
Finland |
Germany |
Poland |
Russian Federation |
Serbia |
Ukraine |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |