St Johns wort (SJW) for mild to moderate depression (MDD) in adolescents
| ISRCTN | ISRCTN99665363 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99665363 |
| Secondary identifying numbers | DEMIJO 1.0 |
- Submission date
- 06/05/2009
- Registration date
- 09/07/2009
- Last edited
- 13/08/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Kölch
Scientific
Scientific
University Medical Center Ulm
Department of Child and Adolescent Psychiatry/Psychotherapy
Steinhövelstr. 5
Ulm
89075
Germany
Study information
| Study design | Parallel group randomised double-blind placebo-controlled multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | St Johns wort (SJW) for mild to moderate depression (MDD) in adolescents: a parallel group, randomised, double-blind, placebo-controlled, multicentre trial |
| Study acronym | DEMIJO |
| Study objectives | 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(s) | Ethik-Kommission der Universität Ulm. Approved 17/03/2010 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | St Johns wort (SJW) |
| Primary outcome measure | 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 study start date | 03/11/2010 |
| Completion date | 01/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 238 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/11/2010 |
| Date of final enrolment | 01/12/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
University Medical Center Ulm
Ulm
89075
Germany
89075
Germany
Sponsor information
University Medical Center Ulm (Germany)
Hospital/treatment centre
Hospital/treatment centre
Department of Child and Adolescent Psychiatry/Psychotherapy
Steinhövelstr. 5
Ulm
89075
Germany
| Website | http://www.uniklinik-ulm.de/ |
|---|---|
"ROR" |
https://ror.org/05emabm63 |
Funders
Funder type
Government
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
