Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

Verified by: Rafa Laboratories, June 2011
First Received: November 13, 2007 | Last Updated: June 23, 2011 | Phase: Phase 4 | Start Date: January 2009
Overall Status: Terminated | Estimated Enrollment: 30
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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...

Brief Summary

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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: November 2010

Intervention(s) in this Clinical Trial

  • Drug: hypericum
    • 250mg tablets twice daily for 8 weeks
  • Drug: fluoxetine
    • 20mg - 40mg daily for 8 weeks

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: A
    • hypericum 250mg tablets twice daily for 8 weeks
  • Active Comparator: B
    • fluoxetine 20mg - 40mg daily for 8 weeks

Outcome Measures for this Clinical Trial

Primary Measures

  • Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit
    • Time Frame: 8 weeks
      Safety Issue?: No

Secondary Measures

  • Percentage of patients with a decrease of CDRS-R score > 30 points from baseline
    • Time Frame: 8 weeks
      Safety Issue?: No
  • Final mean CDRS-R score
    • Time Frame: 8 weeks
      Safety Issue?: No
  • Change in CDRS-R score
    • Time Frame: 8 weeks
      Safety Issue?: No
  • Time to clinical response
    • Time Frame: 8 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Rafa Laboratories Industry

Overall Clinical Trial Officials and Contacts

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

Related Publications

Citations Reporting Results

Findling RL, McNamara NK, O'Riordan MA, Reed MD, Demeter CA, Branicky LA, Blumer JL. An open-label pilot study of St. John's wort in juvenile depression. J Am Acad Child Adolesc Psychiatry. 2003 Aug;42(8):908-14.

Simeon J, Nixon MK, Milin R, Jovanovic R, Walker S. Open-label pilot study of St. John's wort in adolescent depression. J Child Adolesc Psychopharmacol. 2005 Apr;15(2):293-301.

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00557427

Study ID Number: REM-1/MDA

ClinicalTrials.gov Identifier: NCT00557427

Health Authority: Israel: Ministry of Health

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