Trial document




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  DRKS00000287

Trial Description

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Title

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.

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Trial Acronym

DEMIJO

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URL of the Trial

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Brief Summary in Lay Language

Labelled as a phytopharmacon in Germany, SJW has not been put through controlled clinical trials to demonstrate its efficacy, safety and recommended dose in minors in order to obtain its license according to German regulatory procedures. Therefore SJW is labelled for the use in children and adolescents, it is the most frequent prescribed antidepressant in children and adolescents, but efficacy and safety has not been proven as it would be required in case of a synthetic antidepressant. Therefore a sound RCT on SJW in adolescents is a public health imperative in Germany.

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Brief Summary in Scientific Language

This is a Phase 4, multicenter, randomized, double-blind, PBO-controlled, study in adolescents aged 12 to 17 years meeting DSM-IV-TR defined criteria for mild to moderate major depressive disorder (MDD). Safety and efficacy of orally delivered SJW (Neuroplant® 300mg N) will be assessed. The study consists of 2 periods: Period I is a screening period; Period II is a 12-week double-blind acute therapy period. The total duration of the study is approximately 38 weeks. The total number of randomly assigned patients in this study is anticipated to be approximately 216, with approximately 108 assigned to each of 2 arms: SJW (Neuroplant® 300mg N) and PBO.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00000287
  •   2009/12/09
  •   2009/07/09
  •   yes
  •   Approved
  •   301/09, Ethik-Kommission der Universität Ulm
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Secondary IDs

  •   U1111-1112-8086 
  •   2009-013956-62 
  •   99665363  (ISRCTN)
  •   DEMIJO  (Universitätsklinikum Ulm)
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Health Condition or Problem studied

  •   F32.0 -  Mild depressive episode
  •   F32.1 -  Moderate depressive episode
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Interventions/Observational Groups

  •   SJW (600mg/d up to 900mg/d) orally; duration of intervention per patient: 12 weeks
  •   placebo orally; duration of intervention: 12 weeks
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Placebo
  •   Other
  •   Parallel
  •   IV
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Primary Outcome

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.
Primary efficacy endpoint: CGI-I dichotomized 1-2 vs. >= 3 at week 12

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Secondary Outcome

Further measures of efficacy, safety and pharmacokinetics of SJW. Additionally quality of life and social functioning after treatment with SJW.
Key secondary endpoint(s): Improvement in CDRS-R total score and other psychometric scales indicating improvement of symptoms of depression and social functioning at week 6 and 12, hyperforin kinetics at week 6, metabolizer pheno-type
Assessment of safety: Adverse Events (AEs) by monitoring and usual documentation acc. GCP, Adverse Event questionnaires (PAERS, C-SSRS), SHBQ for self-harming/suicidal ideations or attempts

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/11/03
  •   238
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   12   Years
  •   17   Years
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Additional 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 with mild to moderate MDD
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.

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Exclusion Criteria

Other psychiatric disorders
Acute risk of suicide in the opinion of the investigator at Visit 1
Other non-psychiatric disorders as specified as follows:
diagnosis of epilepsy, any intracranial disease
Q above 80
Start of psychotherapy
Treatment with other AD or psychopharmacologically active substances
Contraindications or hypersensitivity to SJW
Treatment with drugs that interact with SJW or CYP3A4

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Addresses

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    • Universitätsklinikum Ulm Klinik für Kinder- und Jugendpsychiatrie/Psychotherapie
    • Steinhövelstr. 5
    • 89075  Ulm
    • Germany
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    • Vivantes Klinikum im FriedrichshainKlinik für Kinder- u. Jugendpsychiatrie, Psychotherapie und Psychosomatik
    • Mr.  Professor Dr. med.  Michael  Kölch 
    • Landsberger Allee 49, Haus 8
    • 10249  Berlin
    • Germany
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    • Universitätsklinikum Ulm Klinik für Kinder- und Jugendpsychiatrie/Psychotherapie
    • Mr.  Professor Dr. med.  Michael  Kölch 
    • Steinhövelstr. 5
    • 89075  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Projektträger im DLR Gesundheitsforschung
    • Heinrich-Konen-Str. 1
    • 53227  Bonn
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2012/08/29
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Trial Publications, Results and other Documents

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