Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

Depression Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00557427
• Other study ID #: REM-1/MDA
• Secondary ID: REM-1/MDA
• Status: Terminated
• Phase: Phase 4
• First received: November 13, 2007
• Last updated: June 23, 2011
• Start date: January 2009
• Est. completion date: November 2010

Study information

• Verified date: June 2011
• Source: Rafa Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rafa Laboratories

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit		8 weeks	No
Secondary	Percentage of patients with a decrease of CDRS-R score > 30 points from baseline		8 weeks	No
Secondary	Final mean CDRS-R score		8 weeks	No
Secondary	Change in CDRS-R score		8 weeks	No
Secondary	Time to clinical response		8 weeks	No