Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression
Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression
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.
Inclusion Criteria:

 -  Signed informed consent

 -  Adolescents aged 12 to 18 years

 -  Patients meeting the criteria for mild to moderate depression according to the DSM-IV
 scale

 -  Physical and laboratory examination at baseline compatible with study criteria

 -  ECG at baseline compatible with study criteria

 -  Score of at least 40 on the Children's Depression Rating Scale - Revised (CDRS-R) at
 baseline

 Exclusion Criteria:

 -  Patients with psychosis, bi-polar disease, schizophrenia or significant developmental
 disorder

 -  Patients with epilepsy

 -  Patients with a history of alcohol or substance abuse in the past year

 -  Initiation of psychotherapy or behavioral therapy in the 2 months prior to screening
 or during the study.

 -  Patients who have previously failed to respond to SSRI's or SRNI's

 -  Patients who have been treated with antidepressants within 2 weeks of screening (4
 weeks if fluoxetine)

 -  Patients with a contraindication to taking either Remotiv or fluoxetine or taking
 medication contraindicated when taking Remotiv or fluoxetine