Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression - Tabular View

Tracking Information

First Received Date ^ICMJE

November 13, 2007

Last Updated Date

January 8, 2009

Start Date ^ICMJE

January 2009

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit [ Time Frame: 8 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00557427 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

Official Title ^ICMJE

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

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: hypericum
Drug: fluoxetine

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

12 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Tali Yacobi

03-9253616 /7

taliyacobi@gmail.com

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00557427

Responsible Party

Study ID Numbers ^ICMJE

REM-1/MDA, REM-1/MDA

Study Sponsor ^ICMJE

Rafa Laboratories

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Rafa Laboratories

Verification Date

January 2009

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