drugset / Trial / NCT00557427
Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression
RandomizedParallel-groupOpen-labelTreatment
Summary
The study is a pilot study where adolescents 12 - 18 years of age with mild to moderate depression will be randomized to receive either hypericum 250mg twice daily or fluoxetine 10mg daily increased to 20mg daily after 1 week and the option to increase to 40mg daily after 4 weeks. Patients will be treated for a total of 8 weeks. Efficacy will be measured using the CDRS-R, BDI-II and the CGI scales. Safety parameters include blood tests, urinalysis and ECG.
Timeline
- Start
- 2009-01
- Primary completion
- 2010-11
- Completion
- 2010-11
Publications
- Results Findling RL, McNamara NK, O'Riordan MA, Reed MD, Demeter CA, Branicky LA, Blumer JL. An open-label pilot study of St. John's wort in juvenile depression. J Am Acad Child Adolesc Psychiatry. 2003 Aug;42(8):908-14. doi: 10.1097/01.CHI.0000046900.27264.2A.
- Results Simeon J, Nixon MK, Milin R, Jovanovic R, Walker S. Open-label pilot study of St. John's wort in adolescent depression. J Child Adolesc Psychopharmacol. 2005 Apr;15(2):293-301. doi: 10.1089/cap.2005.15.293.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluoxetine | Small molecule | 20 mg | — |
| Comparator | Fluoxetine | Small molecule | 40 mg | — |
| Subject | St. John's Wort | Traditional medicine (herbal / TCM) | 250 mg | — |