Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression - Full Text View

Purpose

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.

Condition	Intervention	Phase
Depression	Drug: hypericum Drug: fluoxetine	Phase IV

MedlinePlus related topics:

Depression

ChemIDplus related topics:

Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Rafa Laboratories:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	30
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
A: Experimental hypericum 250mg tablets twice daily for 8 weeks	Drug: hypericum 250mg tablets twice daily for 8 weeks
B: Active Comparator fluoxetine 20mg - 40mg daily for 8 weeks	Drug: fluoxetine 20mg - 40mg daily for 8 weeks

Eligibility

Ages Eligible for Study:	12 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557427

Contacts


Contact: Tali Yacobi	03-9253616 /7	taliyacobi@gmail.com

Locations


Israel
	Schneider Children's Medical Center of Israel	Not yet recruiting
	Petach Tikva, Israel
	Sub-Investigator: Sefi Kronenberg, MD

Sponsors and Collaborators

Rafa Laboratories

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

More Information

Publications of 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.

Study ID Numbers:	REM-1/MDA, REM-1/MDA
First Received:	November 13, 2007
Last Updated:	November 13, 2007
ClinicalTrials.gov Identifier:	NCT00557427
Health Authority:	Israel: Ministry of Health

Keywords provided by Rafa Laboratories:

mild to moderate depression according to the DSM-IV scale

Study placed in the following topic categories:

Fluoxetine

Depression

Mental Disorders

Mood Disorders

Depressive Disorder

Serotonin

Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents

Neurotransmitter Uptake Inhibitors

Serotonin Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Psychotropic Drugs

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Serotonin Uptake Inhibitors

Antidepressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Rafa Laboratories
Information provided by:	Rafa Laboratories
ClinicalTrials.gov Identifier:	NCT00557427