Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

Condition(s) targeted: Depression

Intervention: hypericum (Drug); fluoxetine (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Rafa Laboratories

Official(s) and/or principal investigator(s):
Alan Apter, MD, Principal Investigator, Affiliation: Director, child and adolescent division, Schneider Children's Hospital of Israel, Chairman Dept. of Psychiatry Sackler School of Medicine, Tel-Aviv University

Overall contact:
Tali Yacobi, Phone: 03-9253616 /7, Email: taliyacobi@gmail.com

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.

Official title: Open-Labeled Randomized Comparative Study of the Efficacy and Tolerability of Two Times Daily 250mg Hypericum Versus Once Daily 20 - 40 mg Fluoxetine in Adolescent Patients With Mild to Moderate Depression

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit

Secondary outcome:

Percentage of patients with a decrease of CDRS-R score > 30 points from baseline

Final mean CDRS-R score

Change in CDRS-R score

Time to clinical response

BDI-II change from baseline

CGI change from baseline

Minimum age: 12 Years. Maximum age: 18 Years. Gender(s): Both.

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

Tali Yacobi, Phone: 03-9253616 /7, Email: taliyacobi@gmail.com

Schneider Children's Medical Center of Israel, Petach Tikva, Israel

Starting date: January 2009
Ending date: December 2009
Last updated: January 8, 2009