Condition category
Mental and Behavioural Disorders
Date applied
06/05/2009
Date assigned
09/07/2009
Last edited
13/08/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Kölch

ORCID ID

Contact details

University Medical Center Ulm
Department of Child and Adolescent Psychiatry/Psychotherapy
Steinhövelstr. 5
Ulm
89075
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DEMIJO 1.0

Study information

Scientific title

St John’s 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 John’s 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

http://www.uniklinik-ulm.de/

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

Publication citations

Additional files

Editorial Notes