Prove cliniche Nct

Summary
EudraCT Number:2009-013956-62
Sponsor's Protocol Code Number:DEMIJO
National Competent Authority:Germany - BfArM
Clinical Trial Type:EEA CTA
Trial Status:Prematurely Ended
Date on which this record was first entered in the EudraCT database:2010-03-25
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedGermany - BfArM
A.2EudraCT number2009-013956-62
A.3Full title of the trial
Preparation of Neuroplant® 300mg N in film-coated tablets (St. John´s wort, SJW) in the treatment of mild to moderate Major Depressive Disorder (MDD) in adolescents from 12 to 17 years (inclusive): a parallel group, randomized, double-blind, placebo (PBO)-controlled, multicentre clinical trial to evaluate the efficacy, safety, somatic and behavioral Adverse Events (AEs) and pharmacokinetics of SJW in mild to moderate MDD in adolescents.
A.3.2Name or abbreviated title of the trial where available
St. John’s wort (SJW) for mild to moderate depression (MDD) in adolescents
A.4.1Sponsor's protocol code numberDEMIJO
A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number99665363
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorUniversity Medical Center of the University Ulm
B.1.3.4CountryGermany
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Neuroplant® 300 mg N
D.2.1.1.2Name of the Marketing Authorisation holderDr. Willmar Schwabe GmbH & Co. KG, Willmar-Schwabe-Straße 4, D-76227 Karlsruhe
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.4Pharmaceutical form Film-coated tablet
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1CAS number 8001000713
D.3.9.3Other descriptive nameHYPERICUM PERFORATUM
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number300
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product Yes
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboFilm-coated tablet
D.8.4Route of administration of the placeboOral use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Mild to moderate MDD acc. DSM-IV-TR in adolescents (12−17years inclusive)
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 12.0
E.1.2Level LLT
E.1.2Classification code 10025453
E.1.2Term Major depressive disorder NOS
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main 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%)
E.2.2Secondary objectives of the trial
Further measures of efficacy, safety and pharmacokinetics of SJW. Additionally quality of life and social functioning after treatment with SJW.
E.2.3Trial contains a sub-study No
E.3Principal 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.).
E.4Principal exclusion criteria
•Other psychiatric disorders if they meet criteria according to DSM-IV-TR (current or within the past year) for:

osevere depression (CDRS-R ≥95, CGI-S ≥6)
osevere suicidal symptoms for which in-patient treatment is necessary at the time of enrolment
obipolar-disorder
opervasive development disorder
oacute post traumatic stress disorder
osubstance abuse
oschizophrenia

•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
odiagnosis of epilepsy,
oany 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.
E.5 End points
E.5.1Primary 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.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other 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.8.4.1Number of sites anticipated in Member State concerned15
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial 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
End of trial is last visit of the last patient.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years4
E.8.9.1In the Member State concerned months0
E.8.9.1In the Member State concerned days0
E.8.9.2In all countries concerned by the trial years0
E.8.9.2In all countries concerned by the trial months0
E.8.9.2In all countries concerned by the trial days0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Yes
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) Yes
F.1.2Adults (18-64 years) No
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally Yes
F.3.3.6.1Details of subjects incapable of giving consent
Inclusion of Minors
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state238
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
see protocol chapter 3.7.3 and chapter 4.1.7
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2010-04-26
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion
P. End of Trial
P.End of Trial StatusPrematurely Ended
P.Date of the global end of the trial2012-08-29

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