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 |
Major Depressive Disorder |
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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 | 10025461 |
E.1.2 | Term | Major depressive disorder, recurrent episode, severe degree, without mention of psychotic behavior |
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 | 10025469 |
E.1.2 | Term | Major depressive disorder, single episode, severe degree, without mention of psychotic behavior |
E.1.2 | System Organ Class | 100000004873 |
|
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 | 10025463 |
E.1.2 | Term | Major depressive disorder, single episode |
E.1.2 | System Organ Class | 100000004873 |
|
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 | 10025462 |
E.1.2 | Term | Major depressive disorder, recurrent episode, unspecified degree |
E.1.2 | System Organ Class | 100000004873 |
|
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 | 10025467 |
E.1.2 | Term | Major depressive disorder, single episode, moderate degree |
E.1.2 | System Organ Class | 100000004873 |
|
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 | 10025457 |
E.1.2 | Term | Major depressive disorder, recurrent episode, mild degree |
E.1.2 | System Organ Class | 100000004873 |
|
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 | 10025458 |
E.1.2 | Term | Major depressive disorder, recurrent episode, moderate degree |
E.1.2 | System Organ Class | 100000004873 |
|
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 | 10025470 |
E.1.2 | Term | Major depressive disorder, single episode, unspecified degree |
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 long-term safety and tolerability of brexpiprazole as adjunct treatment to antidepressant (ADT) |
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E.2.2 | Secondary objectives of the trial |
To evaluate the therapeutic effect of flexible dose brexpiprazole as adjunct treatment to ADT on depressive symptoms
To evaluate the therapeutic effect of flexible dose brexpiprazole as adjunct treatment to ADT on clinical global impression
To evaluate the therapeutic effect of flexible dose brexpiprazole as adjunct treatment to ADT on health-related quality of life |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator.
• The patient had MDD at entry in lead-in brexpiprazole studies, 14570A or 14571A, diagnosed according to DSM-IV-TR™.
• The patient agrees to protocol-defined use of effective contraception. |
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E.4 | Principal exclusion criteria |
• The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
• The patient has been diagnosed with a psychiatric disorder other than MDD during the lead-in studies
14570A or 14571A.
• The patient, in the opinion of the investigator or according to C-SSRS, is at significant risk of suicide.
• The patient has any relevant medical history or current presence of systemic disease.
• The patient has, at the Baseline Visit an abnormal ECG that is, in the investigator's opinion, clinically significant.
• The patient has a moderate or severe ongoing adverse event related to study medication from the lead-in studies considered of potential safety risk by the investigator.
• The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Safety
2. Tolerability
3. Risk of suicidality |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1.Up to 52 weeks and a 4-week safety follow up
2. Up to 52 weeks
3. Up to 52 weeks |
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E.5.2 | Secondary end point(s) |
1. Change in depressive symptoms
2. Proportion of patients in remission
3. Change in clinical global impression
4. Change in health-related quality of life (Q-LES-Q-(SF))
5. Change in health-related quality of life (EQ-5D-5L) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Baseline and Week 52
2. Baseline and Week 52
3. Baseline and Week 52
4. Baseline and Week 52
5. Baseline and Week 52 |
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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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
adjunct treatment to open-label, oral, commercially available antidepressant |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 18 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 113 |
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 |
Canada |
Italy |
Romania |
Slovakia |
Sweden |
Argentina |
Australia |
Chile |
Estonia |
Finland |
Germany |
Korea, Republic of |
Latvia |
Lithuania |
Mexico |
Poland |
Russian Federation |
Ukraine |
United Kingdom |
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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The end of the study for an individual patient is defined as the last protocol-specified contact with that patient.
The overall end of the study is defined as the last protocol-specified contact with the last patient ongoing in the study. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |