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

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Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

This study is not yet open for participant recruitment.

Study NCT00557427. Last updated on November 13, 2007. Information provided by Rafa Laboratories

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

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

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Depression

Intervention ^†

Drug: hypericum
Drug: fluoxetine

MEDLINE PMIDs

12874492, 15910213

Links

Recruitment Information Fields

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

Start Date ^†

February 2008

Completion Date

December 2008

Eligibility Criteria ^†

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 ^††

Contact: Tali Yacobi

03-9253616 /7

taliyacobi@gmail.com

Location Countries ^†

Israel

Administrative Information Fields

NCT ID ^†

NCT00557427

Organization ID

REM-1/MDA

Secondary IDs ^††

REM-1/MDA

Study Sponsor ^†

Rafa Laboratories

Collaborators ^††

Investigators ^†

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

November 2007

First Received Date ^†

November 13, 2007

Last Updated Date

November 13, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.