- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00557427
Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression
June 23, 2011 updated by: Rafa Laboratories
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Petach Tikva, Israel
- Schneider Children's Medical Center of Israel
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
hypericum 250mg tablets twice daily for 8 weeks
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250mg tablets twice daily for 8 weeks
Other Names:
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Active Comparator: B
fluoxetine 20mg - 40mg daily for 8 weeks
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20mg - 40mg daily for 8 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients with a decrease of CDRS-R score > 30 points from baseline
Time Frame: 8 weeks
|
8 weeks
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Final mean CDRS-R score
Time Frame: 8 weeks
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8 weeks
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Change in CDRS-R score
Time Frame: 8 weeks
|
8 weeks
|
Time to clinical response
Time Frame: 8 weeks
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8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1097/01.CHI.0000046900.27264.2A.
- 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. doi: 10.1089/cap.2005.15.293.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
November 13, 2007
First Submitted That Met QC Criteria
November 13, 2007
First Posted (Estimate)
November 14, 2007
Study Record Updates
Last Update Posted (Estimate)
June 27, 2011
Last Update Submitted That Met QC Criteria
June 23, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Fluoxetine
Other Study ID Numbers
- REM-1/MDA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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