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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
250mg tablets twice daily for 8 weeks
20mg - 40mg daily for 8 weeks
Schneider Children's Medical Center of Israel
Petah Tikva, Israel
Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit
Time frame: 8 weeks
Percentage of patients with a decrease of CDRS-R score > 30 points from baseline
Time frame: 8 weeks
Final mean CDRS-R score
Time frame: 8 weeks
Change in CDRS-R score
Time frame: 8 weeks
Time to clinical response
Time frame: 8 weeks
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