Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

Phase 4

Terminated

• Conditions: Depression
• Interventions: Drug: hypericum; Drug: fluoxetine

• Registration Number: NCT00557427
• Lead Sponsor: Rafa Laboratories

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-13
• Study First Submitted QC: 2007-11-13
• Study First Posted: 2007-11-14
• Study Start: 2009-01
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-23
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	hypericum	hypericum 250mg tablets twice daily for 8 weeks
B	fluoxetine	fluoxetine 20mg - 40mg daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit	8 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with a decrease of CDRS-R score > 30 points from baseline	8 weeks
Final mean CDRS-R score	8 weeks
Change in CDRS-R score	8 weeks
Time to clinical response	8 weeks

Trial Locations

Locations (1)

Schneider Children's Medical Center of Israel; 🇮🇱 Petach Tikva, Israel