Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rafa Laboratories
• Treatments: Fluoxetine

Criteria

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