Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DEMIJO 1.0
Study information
Scientific title
St Johns wort (SJW) for mild to moderate depression (MDD) in adolescents: a parallel group, randomised, double-blind, placebo-controlled, multicentre trial
Acronym
DEMIJO
Study hypothesis
Mild to moderate depression (MDD) in adolescents is a severe disorder with high risk of chronic impairment and poor prognosis without sufficient treatment. Recovery in mild to moderate depression will hardly be achieved with only supportive treatment. The following findings in adult St John's wort (SJW) could be an efficacious treatment option for MDD in minors without severe side effects. For SJW no sound data about response/efficacy in adolescents are available. The results of the proposed study will have a tremendous impact on clinical practice given the fact that SJW is one of the most frequently used drugs in minors against MDD in Germany without a sound database neither on efficacy nor on adverse events (AE).
Anticipated start date has been modified from 01/09/2009 to 03/11/2010.
Please note that as of 13/08/2012, this trial is no longer recruiting patients. The anticipated end date has been updated from 01/09/2013 to 01/12/2012
Ethics approval
Ethik-Kommission der Universität Ulm. Approved 17/03/2010
Study design
Parallel group randomised double-blind placebo-controlled multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Mild to moderate depression (MDD)
Intervention
Experimental intervention: SJW (600 mg/d) and treatment as usual (TAU = psychological support)
Control intervention: placebo and TAU
Acute treatment period: 12 weeks; 13 study visits: 6 office and 7 phone; a follow-up assessment at 24 weeks after the end of the 12-week double-blind acute therapy period is planned.
Intervention type
Drug
Phase
Phase IV
Drug names
St Johns wort (SJW)
Primary outcome measures
Efficacy of SJW compared with placebo in the acute treatment of adolescents. Measured at baseline and weekly during treatment period.
Secondary outcome measures
1. Efficacy
2. Safety
3. Pharmacokinetics
4. Quality of life
5. Social functioning
Measured at baseline and weekly during treatment period.
Overall trial start date
03/11/2010
Overall trial end date
01/12/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. 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.
2. Written consent and assent of the caregivers and participants which is dated by the caregivers/participants before any study exam or procedure is conducted
3. Adolescents (both sexes, aged 12 - 17 [inclusive] years) with mild to moderate MDD at time of signing consent/assent and first visit
4. Symptoms of depression stable for about 6 weeks before entering the trial
5. Female patients must test negative for pregnancy during screening. 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.
6. 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
238
Participant exclusion criteria
1. Other psychiatric disorders (current or within the past year) for:
1.1. Severe depression
1.2. Severe suicidal symptoms for which in-patient treatment is necessary at the time of enrolment
1.3. Bipolar-disorder
1.4. Acute post traumatic stress disorder
1.5. Substance abuse
1.6. Schizophrenia
2. Acute risk of suicide in the opinion of the investigator at Visit 1
3. Other non-psychiatric disorders as specified as follows:
3.1. Diagnosis of epilepsy
3.2. Any intracranial disease
4. Intelligence quotient (IQ) less than or equal to 80
5. Start of psychotherapy (psychotherapy will be allowed if psychotherapy started more than 3 months ago)
6. 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)
7. Prior ineffective treatment with SJW or other AD (if treated over a period of more than 1 months)
8. Contraindications or hypersensitivity to SJW (e.g. light allergic skin reactions) or to similar preparation or components of the study medication
9. Pregnancy and breast-feeding
10. Treatment with drugs that interact with SJW or CYP3A4 (e.g., immunosupressants and anti-human immunodeficiency virus [HIV] medication, e.g., ciclosporin, indinavir, other protease-inhibitors; cyotstatics: e.g., imatinib,; anti-coagulant medication: e.g., warfarin/cumarine); medication with pharmacokinetic-antagonistic interactions, e.g., digoxin, theophyllin, hormonal contraceptives, or verapamil, simvastatin, midazolam; medication with pharmacodynamic synergistic interactions, e.g., antidepressants as selective serotonin reuptake inhibitors (SSRI)
11. Patients with intolerance against lactose will be excluded as placebo contains lactose
12. Participation in another clinical trial during the trial or before 3 months of entering the trial
Recruitment start date
03/11/2010
Recruitment end date
01/12/2012
Locations
Countries of recruitment
Germany
Trial participating centre
University Medical Center Ulm
Ulm
89075
Germany
Sponsor information
Organisation
University Medical Center Ulm (Germany)
Sponsor details
Department of Child and Adolescent Psychiatry/Psychotherapy
Steinhövelstr. 5
Ulm
89075
Germany
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary