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Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression
This study is not yet open for participant recruitment.
Study NCT00557427   Information provided by Rafa Laboratories
First Received: November 13, 2007   Last Updated: January 8, 2009   History of Changes

November 13, 2007
January 8, 2009
January 2009
 
Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit [ Time Frame: 8 weeks ]
Same as current
Complete list of historical versions of study NCT00557427 on ClinicalTrials.gov Archive Site
  • Percentage of patients with a decrease of CDRS-R score > 30 points from baseline [ Time Frame: 8 weeks ]
  • Final mean CDRS-R score [ Time Frame: 8 weeks ]
  • Change in CDRS-R score [ Time Frame: 8 weeks ]
  • Time to clinical response [ Time Frame: 8 weeks ]
  • BDI-II change from baseline [ Time Frame: 8 weeks ]
  • CGI change from baseline [ Time Frame: 8 weeks ]
Same as current
 
Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression
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.

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Depression
  • Drug: hypericum
  • Drug: fluoxetine
  • Experimental: hypericum 250mg tablets twice daily for 8 weeks
  • Active Comparator: fluoxetine 20mg - 40mg daily for 8 weeks

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
30
December 2009
 

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
Both
12 Years to 18 Years
No
Contact: Tali Yacobi 03-9253616 /7 taliyacobi@gmail.com
Israel
 
NCT00557427
 
REM-1/MDA, REM-1/MDA
Rafa Laboratories
 
Principal Investigator: 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
Rafa Laboratories
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP