Mild to moderate depression (MDD) Mental and Behavioural Disorders Depressive episode
Conditions
Interventions
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.
Sponsors
University Medical Center Ulm (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of SJW compared with placebo in the acute treatment of adolescents. Measured at baseline and weekly during treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy 2. Safety 3. Pharmacokinetics 4. Quality of life 5. Social functioning Measured at baseline and weekly during treatment period. | — |
Countries
Germany
Outcome results
None listed