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 |
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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 | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025454 |
E.1.2 | Term | Major depressive disorder, recurrent episode |
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 |
study if NPY decreases symptoms of depression |
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E.2.2 | Secondary objectives of the trial |
study any changes in QIDS-SR16 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Male and female patients, age ≥25 2.Signed informed consent 3.Patients diagnosed with recurrent major depression according to DSM-5 confirmed with SCID, and a history of at least one previous episode, currently in treatment with a minimum MADRS-M score of 28 4.Female patient of child bearing age must be willing to ensure that they use effective contraception during the study (e.g. combination of barrier method and spermicide; sterilization, hormone implants, hormone injections, intrauterine devices, or vasectomised partner) 5.Patient has acceptable laboratory, vital signs and ECG results (as judged by the investigator)
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E.4 | Principal exclusion criteria |
1.Any changes in antidepressant treatment within 3 weeks before study inclusion 2.Current manic or mixed affective episode or schizoaffective disease as well as patients with suicide risk 3. Nasal pathology (e.g. chronic rhinitis) that can affect the uptake of NPY 4.Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial 5.Current substance abuse or dependence 6.Female patient who is pregnant, lactating or planning pregnancy during the course of the trial 7.Positive alcohol breath test 8.Participation in another study with an investigational drug within 3 months before study inclusion
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction in MADRS-M scores from Screening to Visit 6 (Day 11)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From Screening to Visit 6 (Day 11)
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E.5.2 | Secondary end point(s) |
reduction in MADRS-M scores from Screening to Visit 5 (Day 4) reduction in MADRS-M scores from Screening to Visit 7 (Day 18)
reduction in QIDS-SR16 from Screening to Visit 5 (Day 4) reduction in QIDS-SR16 from Screening to Visit 6 (Day 11) reduction in QIDS-SR16 from Screening to Visit 7 (Day 18)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
reduction in MADRS-M scores from Screening to Visit 5 (Day 4) reduction in MADRS-M scores from Screening to Visit 7 (Day 18)
reduction in QIDS-SR16 from Screening to Visit 5 (Day 4) reduction in QIDS-SR16 from Screening to Visit 6 (Day 11) reduction in QIDS-SR16 from Screening to Visit 7 (Day 18)
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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 | 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 | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 trial is the date of the last visit of the last patient. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |