drugset / Trial / NCT00557427

Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

NCT00557427

Phase 4 Terminated 30 enrolled Rafa Laboratories
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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluoxetine Small molecule 20 mg
Comparator Fluoxetine Small molecule 40 mg
Subject St. John's Wort Traditional medicine (herbal / TCM) 250 mg

Indications