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Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

NCT00557427 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-06-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

hypericum

250mg tablets twice daily for 8 weeks

DRUG

fluoxetine

20mg - 40mg daily for 8 weeks

Sponsors & Collaborators

  • Rafa Laboratories

    lead INDUSTRY

Principal Investigators

  • Alan Apter, MD · Director, child and adolescent division, Schneider Children's Hospital of Israel, Chairman Dept. of Psychiatry Sackler School of Medicine, Tel-Aviv University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00557427 on ClinicalTrials.gov