E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major Depressive Disorder (MDD) |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
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 | 10037175 - Psychiatric disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
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 |
To evaluate the efficacy of NBI-1065845 compared with placebo in subjects with MDD on improving symptoms of depression as measured by the Montgomery Åsberg Depression Rating Scale (MADRS). |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the efficacy of NBI-1065845 compared with placebo in subjects with MDD on improving: o Overall severity of and improvement in depression o Depression response and remission rates, as measured by MADRS o Subject-rated depression severity o Quality of life • To assess for onset of antidepressant efficacy • To evaluate the safety and tolerability of NBI-1065845 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.The subject has completed written informed consent. 2. At the time of signing the informed consent, subject must be 18 to 65 years of age, inclusive. 3.The subject has a primary diagnosis of recurrent Major Depressive Disorder (MDD) or persistent depressive disorder. 4.Subject must have had inadequate response to antidepressant treatment. 5.Total HAM-D17 score ≥22 at screening. 6.Subjects currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥ 8 weeks prior to screening. Subjects not currently receiving pharmacological treatment for depression must have received the most recent antidepressant medication (s) for ≥ 8 weeks in the current prior to episode of depression. 7.Subjects must be willing and able to comply with all study procedures and restrictions. |
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E.4 | Principal exclusion criteria |
1.Subject is pregnant or breastfeeding or plans to become pregnant during the study. 2.Subject has an unstable medical condition or unstable chronic disease. 3.Subject has a history of neurological abnormalities. 4.Subject has a current or prior psychiatric disorder that was the primary focus of treatment other than MDD. 5.The subject’s depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT). 6.The subject has an alcohol or substance use disorder. 7.In the Investigator’s opinion, the subject is not capable of adhering to the protocol requirements |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28 |
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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) |
• Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56 • Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28 and Day 56 •Response, defined as ≥50% decrease in MADRS from baseline, at Day28 and Day 56 (Time Frame: baseline and Days 28 and 56) • Remission, defined as MADRS ≤10, at Days 28 and 56 (Time Frame: Days 28 and 56) •Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score at Day 28 and Day 56
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
•For Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56 - Day 56 • For all others - Days 28 and 56
Please refer to the protocol for more details |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
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 | 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 | 7 |
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 |
United States |
Bulgaria |
Czechia |
Poland |
Slovakia |
Sweden |
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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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Last visit of the last subject or last scheduled procedure shown in the Schedule of Assessments for the last subject in the study globally. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |