E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild to moderate MDD acc. DSM-IV-TR in adolescents (12−17years inclusive) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025453 |
E.1.2 | Term | Major depressive disorder NOS |
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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 |
Assessment of efficacy of SJW (Neuroplant® 300mg N) compared with PBO in the acute treatment of adolescents who meet criteria for mild to moderate MDD Hypothesis: SJW is more effective compared to PBO (response rates 60% to 40%)
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E.2.2 | Secondary objectives of the trial |
Further measures of efficacy, safety and pharmacokinetics of SJW. Additionally quality of life and social functioning after treatment with SJW. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Participant is able to understand the study and its procedures according to his or her age. Caregivers have to be able to understand the study, the study procedures, individual consequences for their child. • Written consent and assent of the caregivers and participants which is dated by the caregivers/participants before any study exam or procedure is conducted. • Adolescents (both sexes, age: 12–17 (incl.) years) with mild to moderate MDD according to DSM-IV-TR (296.xx/300.4/311) at time of signing consent/assent and first visit. These diagnoses will be supported by the use of the K-SADS. • CGI-S ≥3, • CDRS-R total score ≥45 but not ≤ 95, • Symptoms of depression stable for about 6 weeks before entering the trial. • Female patients must test negative for pregnancy during screening at baseline-visit. Furthermore, female patients must agree to abstain from sexual activity or to use a reliable method of birth control as determined by the investigator during the study. • Patient’s parent/legal representative and patient, if capable, are judged to be reliable by the investigator to keep all appointments for clinical visits, tests, and procedures required by the protocol. • Patients must be capable of swallowing study drug whole (without opening the film-coated tablet, crushing, dissolving, dividing, etc.). |
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E.4 | Principal exclusion criteria |
• Other psychiatric disorders if they meet criteria according to DSM-IV-TR (current or within the past year) for:
o severe depression (CDRS-R ≥95, CGI-S ≥6) o severe suicidal symptoms for which in-patient treatment is necessary at the time of enrolment o bipolar-disorder o pervasive development disorder o acute post traumatic stress disorder o substance abuse o schizophrenia
• In addition, patients with an Axis II disorder (e.g. borderline personality disorder) will be excluded if, in the judgment of the investigator, the Axis II disorder would interfere significantly with protocol compliance. • Acute risk of suicide in the opinion of the investigator at Visit 1 • Other non-psychiatric disorders as specified as follows o diagnosis of epilepsy, o any intracranial disease • IQ ≤80 • Start of psychotherapy (psychotherapy will be allowed if psychotherapy started more than 3 months ago) and should be stable over Period II • Treatment with other AD or psychopharmacologically active substances (treatment should be have stopped 5half-lives before entering the trial), except short-term benzodiazepine treatment/corticoid treatment/treatment with methylphenidate (no time restriction but start with stimulant medication must be 3 months before entering the trial), • Prior ineffective treatment with SJW or other AD (if treated over a period of more than 1 month). Have a lack of response to 2 or more adequate treatment trials of antidepressants at a clinically appropriate dose for a minimum of 4 weeks for the same MDD episode. In addition, patients who have had a lack of response of their current medication will be excluded. • Contraindications or hypersensitivity to SJW (e.g. light allergic skin reactions) or to similar preparation or components of the study medication, • Pregnancy and breast-feeding; sexual active females must use a safe method of contraception (not hormonal contraceptives). Patients using hormonal contraceptives will be informed to use a second safe safe method of contraception. . • Treatment with drugs that interact with SJW or CYP3A4 (e.g. immunsupressants and anti-HIV-medication: e.g. cyclosporin, indinavir, other protease-inhibitors, cyotstatics: e.g. imatinib, anticoagulant medication: e.g. warfarin/cumarine); medication with pharmacokinetic-antagonistic interactions, e.g. digoxin, theophyllin or verapamil, simvastatin, midazolam; medication with pharmacodynamic synergistic interactions, e.g. antidepressants as SSRI. • Patients with intolerance against lactose will be excluded as PBO contains lactose. • Participation in another clinical trial during the trial or before 3 months of entering the trial • If patients are the children of investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a child or sibling, whether biological or legally adopted. • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy endpoint: CGI-I dichotomized 1-2 vs. ≥ 3 at week 12
Response is defined as a clinician-rated Clinical Global Impression (CGI) improvement score of 1 or 2 (markedly or moderately improved) at the end of treatment phase (Study period II). Non response is defined by CGI-I ≥ 3 at week 12. Response rate is defined in percentage of these patients with a CGI-I 1-2 versus these patients with a CGI-I ≥ 3 at week 12.
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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.8.3 |
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 | 15 |
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 | Information not present in EudraCT |
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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End of trial is 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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |