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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

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 ]

Estimated Enrollment:	30
Study Start Date:	January 2009
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

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	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:

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
Study First Received:	November 13, 2007
Last Updated:	February 4, 2010
ClinicalTrials.gov Identifier:	NCT00557427 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Rafa Laboratories:

mild to moderate depression according to the DSM-IV scale

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions

Behavioral Symptoms
Fluoxetine
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010