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.

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. - DEMIJO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000287

Enrollment

238

Registered

2009-12-09

Start date

2010-11-03

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F32.0 F32.1

Interventions

Group 1: SJW (600mg/d up to 900mg/d) orally

duration of intervention per patient: 12 weeks Group 2: placebo orally

duration of intervention: 12 weeks

Eligibility

Sex/Gender

All

Age

12 Years to 17 Years

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactMichael Kölch

Universitätsklinikum Ulm Klinik für Kinder- und Jugendpsychiatrie/Psychotherapie

michael.koelch@uniklinik-ulm.de0731 - 500 61608

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026