E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with Treatment Resistant Major Depression |
Depressione Maggiore Resistente al trattamento. |
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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 | 15.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10037175 |
E.1.2 | Term | Psychiatric disorders |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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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 |
The purpose of this study is to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression. |
Lo scopo dello studio è quello di valutare la tollerabilità e la sicurezza a lungo termine di BMS-820836 in pazienti con depressione maggiore resistente al trattamento |
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E.2.2 | Secondary objectives of the trial |
To assess the long term safety and tolerability of 3 target doses of BMS- 820836 (0.5, 1 or 2mg/day) in the treatment of subjects with TRD from randomization baseline through 54 weeks of the rollover study as measured by the frequency and severity of AEs, frequency of SAEs and discontination due to AEs. |
Valutare la tollerabilità e la sicurezza a lungo termine delle 3 dosi target di BMS-820836 (0,5,1 e 2 mg/giorno) per il trattamento di soggetti con depressione resistente al trattamento dalla visita di randomizzazione (Baseline- visita Iniziale dello studio di rollover) fino a tutte le 54 settimane dello studio di Rollover.Saranno misurati la frequenza e la severità degli eventi avversi,la frequenza degli eventi avversi seri (SAEs) e la discontinuazione dal trattamento dovuta agli eventi avversi. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Patients randomized in parent study who complete CN162-006 and CN162-007 who consent to enter the rollover study. |
Soggetti randomizzati nello studio originario (parent study) che hanno completato uno dei due studi originari CN162-006 e CN162-007 e che hanno dato il loro consenso ad entrare nello studio di Rollover |
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E.4 | Principal exclusion criteria |
1) Patients who represent a significant risk of committing suicide based on the clinical judgment of the investigator, history or routine psychiatric status exam. 2) Patients with a Cardiovascular System Organ Class adverse event(s) occurring in patients study (CN162-006 or CN162-007) that in the investigator judgment is clinically significant and would impact safety of the subject inthe current study (including but not limited to left bundle branch block or prolonged QTc) 3)In addition, patients should be excluded if they have any laboratory test, vital signs, ECG or clinical findings that in the investigator`s judgment is clinically significantly abnormal and could impact the safety of the patient or the interpretation of study assessments in the current study. |
1) soggetti che presentano un rischio significativo di commettere suicidio, in base al giudizio clinico dello sperimentatore, all`anamnesi o agli esami di routine delle condizioni psichiatriche; 2) soggetti con evento(i) avverso(i) a carico degli Organi del Sistema Cardiovascolare manifestatosi(isi) nello studio originario (CN162006 o CN162007) che, a giudizio dello sperimentatore, è(sono) clinicamente significativo(i) e potrebbe(ro) compromettere la sicurezza del soggetto nello studio attuale (inclusi, ma non esclusivamente, un blocco di branca sinistro o un prolungamento del QTc); 3) inoltre, devono essere esclusi i soggetti con anomalie degli esami di laboratorio, dei parametri vitali, dell`ECG o dei risultati clinici che, a giudizio dello sperimentatore, sono clinicamente significative e potrebbero compromettere la sicurezza del soggetto o l`interpretazione delle valutazioni dello studio attuale. |
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E.5 End points |
E.5.1 | Primary end point(s) |
the primary endpoint for this study is to compare the long term effect of BMS- 820836 THROUGH 54 WEEKS IN THE CHANGE FROM baseline in blood pressure for patient whit depression |
L'endpoint primario di questo studio è di confrontare l’effetto a lungo termine di BMS-820836 sulla pressione sanguigna dei soggetti con depressione dalla visita iniziale del rollover (baseline) alle 54 settimane di trattamento. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Frequency and severity of adverse events (AE) , frequency of serious adverse events and discontinuation due to AE's |
la frequenza e la severità degli eventi avversi, la frequenza degli eventi avversi seri (SAEs) e la discontinuazione dal trattamento dovuta agli eventi avversi. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
From randomization baseline through 54 weeks of the rollover study |
dalla visita iniziale di randomizzazione del rollover (baseline) alle 54 settimane di trattamento dello studio di Rollover. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
stesso farmaco sperimentale a diversi dosaggi |
same drug at different dosage |
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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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
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 |
Argentina |
Australia |
Brazil |
Canada |
India |
Puerto Rico |
South Africa |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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Week 58 will be the last study visit for current study protocol. This visit will be a phone call from the investigator or designee to assess any adverse events the subject may have experienced during the Washout Phase as well as to complete the withdrawal assessments. |
Il week 58 sarà l’ultima visita dello studio attuale. Questa visita sarà telefonica dallo sperimentatore o da delegato per valutare ogni evento avverso che il paziente ha avuto nel periodo di Washot e completare le valutazioni di interruzione |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 37 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 37 |
E.8.9.2 | In all countries concerned by the trial days | 0 |