| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Major Depressive Disorder |
| Disturbo Depressivo Maggiore |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| 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 | PT |
| E.1.2 | Classification code | 10057840 |
| E.1.2 | Term | Major depression |
| E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
|
| 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 primary objective is to demonstrate the efficacy of SPD489 when used as augmentation therapy in the treatment of major depressive disorder (MDD) in inadequate responders following an 8 week course of treatment with an antidepressant, as measured by the mean change in Montgomery Ǻsberg Depression Rating Scale (MADRS) total scores. |
| l’obiettivo primario è dimostrare l’efficacia di SPD489 impiegato come terapia di potenziamento nel trattamento del disturbo depressivo maggiore (MDD, Major Depressive Disorder) in soggetti con risposta inadeguata dopo un ciclo di trattamento con antidepressivo per 8 settimane, misurata in base alla variazione media dei punteggi totali ottenuti alla scala di valutazione della depressione di Montgomery-Ǻsberg (MADRS, Montgomery-Ǻsberg Depression Rating Scale). |
|
| E.2.2 | Secondary objectives of the trial |
The key secondary objective is to demonstrate the effect of SPD489, when used as augmentation therapy in the treatment of MDD in inadequate responders following an 8-week course of treatment with an antidepressant, on quality of life (QoL) as measured by the Sheehan Disability Scale (SDS).
Additional secondary opbjectives are described in the protocol. |
L’obiettivo secondario principale è dimostrare gli effetti sulla qualità della vita (QoL, Quality of Life) di SPD489 impiegato come terapia di potenziamento nel trattamento del MDD in soggetti con risposta inadeguata dopo un ciclo di trattamento con antidepressivo per 8 settimane, misurata in base alla scala di disabilità di Sheehan (SDS, Sheehan Disability Scale).
Gli obbiettivi secondari aggiuntivi sono descritti nel protocollo |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
| - Subject has a primary diagnosis of non-psychotic MDD (single or recurrent) as defined by Structured Clinical Interview for Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition – Text Revision (SCID-CT) that has lasted 8 weeks prior to the Screening Visit (Visit 1). - Subject has a MADRS total score 24 at the Lead-in Baseline Visit (Visit 2) |
| - Soggetti con diagnosi primaria di MDD non psicotico (monoepisodico o ricorrente), definito tramite l’intervista clinica strutturata per il Manuale diagnostico e statistico dei disturbi mentali, IV edizione, Testo riveduto (DSM-IV) che duri da 8 settimane prima della visita di screening (Visita 1). - Soggetti con un punteggio totale MADRS 24 alla visita basale della fase d’induzione (Visita 2). |
|
| E.4 | Principal exclusion criteria |
| - Subject whose current episode of MDD has not responded to an adequate treatment regimen (at least 6 weeks of treatment at the maximum tolerated adult dose approved for the indication) with 2 or more approved single antidepressant agents. Any subject whose current episode of MDD has not responded to an approved adjunctive treatment strategy is to be excluded. - Subject who has a lifetime history of treatment resistant depression, defined as having not responded to adequate treatment (at least 8 weeks of treatment at the maximum tolerated adult dose approved for the indication) with 2 or more treatment regimens, including, distinct classes of approved single antidepressant agents and adjunctive treatment strategies. - Subject is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt within the past 3 years, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator. - Subject has a current comorbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms. Excluded are: any significant Axis II disorder (including borderline personality disorder), any bipolar disorder, any current or lifetime psychosis, post traumatic stress disorder, obsessive compulsive disorder, any pervasive development disorder, anorexia nervosa and bulimia nervosa. - a history of serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a simulant medication, a history of moderate to severe hypertension or an average (of 3 readings) resting sitting systolic blood pressure >139mmHg or an average (of 3 readings) diastolic blood pressure >89mmHg at the Screening Visit (Visit 1) and/or the Lead-in Baseline Visit (Visit 2), or current chronic or acute illness or unstable medical conditions that may deteriorate that could confound the results of safety assessments, increase risk to subjetc, or lead to difficulty complying with the protocol. |
| - Soggetti il cui episodio attuale di MDD non abbia risposto a un regime terapeutico adeguato (almeno 6 settimane di trattamento alla massima dose tollerata per adulti e approvata per quella indicazione) con 2 o più agenti antidepressivi approvati in monoterapia. Devono essere esclusi i soggetti il cui episodio attuale di MDD non abbia risposto a strategie terapeutiche aggiuntive approvate. - Soggetti con una anamnesi permanente di depressione resistente a terapia, definita come una mancanza di risposta a un trattamento adeguato (almeno 8 settimane di trattamento alla massima dose tollerata per adulti e approvata per quella indicazione) con 2 o più regimi terapeutici, che includano classi distinte di agenti antidepressivi approvati in monoterapia e strategie terapeutiche aggiuntive. - Soggetti considerati, a giudizio dello Sperimentatore, a rischio di suicidio, che abbiano tentato il suicidio negli ultimi 3 anni o diano attualmente mostra di idee suicide attive. - Soggetti con comorbilità psichiatrica in atto controllata da farmaci non consentiti dallo studio oppure non controllata e associata a sintomi importanti. Sono da escludere: disturbi importanti di Asse II (incluso il disturbo borderline di personalità), disturbi bipolari, psicosi attuali o permanenti, disturbo post-traumatico da stress, disturbo ossessivo-compulsivo, disturbi pervasivi dello sviluppo, anoressia nervosa e bulimia nervosa. -Storia clinica di gravi problemi cardiaci che possono provocare un'aumentata vulnerabilità degli effetti simpatomimetici di un farmaco stimolante, anamnesi di ipertensione moderata o severa oppure con valori pressori sistolici medi (su 3 letture) rilevati a riposo e da seduti di >139 mmHg o valori pressori diastolici medi (su 3 letture) di >89 mmHg alla visita di screening (Visita 1) e/o alla visita basale della fase d’induzione (Visita 2), o una patologia concomitante cronica eo acuta o unha condizione medica instabile che possa deteriorare e possa confindere i risultati delle valutazioni di sicurezza, aumentare il rischio dei soggetti o condurre a difficoltà nel rispetto del protocollo. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Change from the Augmentation Baseline Visit (Visit 8) to Visit 14 in MADRS total score. |
| variazione del punteggio totale MADRS dalla visita basale della terapia di potenziamento (Visita 8) alla Visita 14. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Change from the Augmentation Baseline Visit (Visit 8) to Visit 14 in MADRS total score. |
| variazione del punteggio totale MADRS dalla visita basale della terapia di potenziamento (Visita 8) alla Visita 14. |
|
| E.5.2 | Secondary end point(s) |
| Change from the Augmentation Baseline Visit (Visit 8) to Visit 14 in SDS total score. Addictional secondary endoints are described in the Protocol. |
| variazione del punteggio totale SDS ottenuto alla Visita 14 rispetto alla visita basale della terapia di potenziamento (Visita 8). Gli endpoints secondari aggiuntivi sono descritti nel protocollo |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Change from the Augmentation Baseline Visit (Visit 8) to Visit 14 in SDS total score. Addictional secondary endoints are described in the Protocol. |
| variazione del punteggio totale SDS ottenuto alla Visita 14 rispetto alla visita basale della terapia di potenziamento (Visita 8). Gli endpoints secondari aggiuntivi sono destritti nel protocollo |
|
| 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 | 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 | Yes |
| E.6.13.1 | Other scope of the trial description |
| withdrawal of symptoms |
| scomparsa dei sintomi |
|
| 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 | Yes |
| E.8.1.7.1 | Other trial design description |
| titolazione flessibile della dose |
| flexible dose tritation |
|
| 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 | 6 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 61 |
| 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 |
|
| 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
|
|
| 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 | 12 |
| 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 | 20 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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