E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post-traumatic stress disorder (PTSD) |
Disordine Post-Traumatico da stress (DPTS) |
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E.1.1.1 | Medical condition in easily understood language |
Post-traumatic stress disorder (PTSD) |
Disordine Post-Traumatico da stress (DPTS) |
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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 | PT |
E.1.2 | Classification code | 10036316 |
E.1.2 | Term | Post-traumatic stress disorder |
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 |
To evaluate the efficacy of brexpiprazole up to 3 mg/day as adjunctive treatment to paroxetine or sertraline on PTSD symptoms |
valutare l'efficacia di 1-3 mg/die di brexpiprazolo sui sintomi di DPTS, quale trattamento aggiuntivo a paroxetina o sertralina |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of brexpiprazole up to 3 mg/day on global clinical impression
- To evaluate the efficacy of brexpiprazole up to 3 mg/day on sleep quality
- To evaluate the efficacy of brexpiprazole up to 3 mg/day on depressive and anxiety symptoms
- To evaluate the efficacy of brexpiprazole up to 3 mg/day on functioning
- To evaluate the efficacy of brexpiprazole up to 3 mg/day on health-related quality of life
- To evaluate the safety and tolerability of up to 3 mg/day brexpiprazole
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valutare l'efficacia di 1-3 mg/die di brexpiprazolo su:
• impressione clinica globale;
• qualità del sonno;
• sintomi depressivi e di ansia;
• funzioni;
• qualità della vita correlata alla salute.
•valutare la sicurezza e la tollerabilità di 1-3 mg/die di brexpiprazolo
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E.2.3 | Trial contains a sub-study | No |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
ANALISI ESPLORATIVA DI FARMACOGENETICA
L’obiettivo è quello di raccogliere e conservare campioni genetici (DNA) per un eventuale studio futuro atto a scoprire se sia possibile utilizzare un gene (o una combinazione di geni) al fine di prevedere la risposta a brexpiprazolo. Inoltre, potrebbe essere condotto uno studio per tentare di individuare i geni che sono correlati a questa indicazione.
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E.3 | Principal inclusion criteria |
• The patient has PTSD, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).
• The patient has a pre-defined Clinician-Administered PTSD Scale Part 2 (CAPS-2) total score at Screening and Baseline Visits.
• The reported duration of the PTSD is at least 3 months. |
• Il paziente è affetto da DPTS, diagnosticata secondo i criteri del DSM-IV-TR™ e confermata dalla Mini International NeuropsychiatricInterview (MINI).
• Alle visite di screening e basale il paziente presenta un punteggio totale ≥70 sulla parte 2 della scala PTSD (Disturbo post-traumatico da stress) somministrata dal medico (Clinician-Administered PTSD Scale Part 2 (CAPS-2)).
• La durata riportata del DPTS è di almeno 3 mesi.
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E.4 | Principal exclusion criteria |
• The index traumatic event that led to development of PTSD took place more than 15 years before screening.
• The patient has a severe personality disorder that in the investigator's opinion may
interfere with the conduct of the study.
• The patient is at significant suicidal risk. |
• L'indice di evento traumatico che ha provocato lo sviluppo del DPTS si è verificato più di 15 anni prima dello screening.
• Il paziente ha un grave disturbo della personalità che secondo l'opinione dello sperimentatore potrebbe interferire con la conduzione dello studio.
• Il paziente è a forte rischio di suicidio.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from randomisation in PTSD symptoms using CAPS-2 total score |
-variazione del punteggio totale CAPS-2 dalla randomizzazione |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline and Week 28 |
dal basale alla settimana 28 |
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E.5.2 | Secondary end point(s) |
- Change from randomisation in global clinical impression using CGI-S score
- Change from randomisation in functioning using SDS score
- Safety - number of adverse events
- Tolerability - number of withdrawals
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-Impressione clinica globale: variazione del punteggio CGI-S dalla randomizzazione
-Funzioni: variazione del punteggio SDS dalla randomizzazione
-Endpoint di sicurezza: eventi avversi
-Tollerabilità: numero di ritiri
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Change from randomisation in global clinical impression using CGI-S score -Time Frame: Baseline and Week 28
- Change from randomisation in functioning using SDS score -Time Frame:Baseline and Week 28
- Safety - number of adverse events-Time Frame:Up to 28 weeks and a 30-day telephone contact or clinic visit
- Tolerability - number of withdrawals - Time Frame:Up to 28 weeks
Up to 28 weeks and a 30-day telephone contact or
clinic visit |
Impressione clinica globale: variazione del punteggio CGI-S dalla randomizzazione alla settimana 28.
Funzioni: variazione del punteggio SDS dalla randomizzazione alla settimana 28.
Sicurezza: numero di eventi avversi-Time: fino a 28 settimane ed un contatto telefonico o visita clinica ogni trenta giorni
Tollerabilità: numero di ritiri: fino a 28 settimane e un contatto telefonico o visita clinica ogni trenta giorni
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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 | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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 | 2 |
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 | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 36 |
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 |
Mexico |
United States |
France |
Argentina |
Denmark |
Italy |
Sweden |
Estonia |
Finland |
Poland |
Serbia |
South Africa |
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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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The last protocol-specified contact with the last patient ongoing in the study. Last contact may be via Telephone. |
: L'ultimo contatto specificato nel protocollo con l'ultimo paziente in corso nello studio. L’ultimo contatto può essere telefonico. |
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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 | 9 |