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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00557427 |
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Date of registration:
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13/11/2007 |
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Primary sponsor: |
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Public title:
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Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression
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Scientific title:
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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 |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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30 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00557427 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Israel
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Contacts
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Name:
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Alan Apter, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Director, child and adolescent division, Schneider Children's Hospital of Israel, Chairman Dept. of Psychiatry Sackler School of Medicine, Tel-Aviv University |
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Key inclusion & exclusion criteria
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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
Age minimum:
12 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Depression
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Intervention(s)
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Drug: fluoxetine
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Drug: hypericum
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Primary Outcome(s)
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Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Change in CDRS-R score
[Time Frame: 8 weeks]
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Final mean CDRS-R score
[Time Frame: 8 weeks]
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Percentage of patients with a decrease of CDRS-R score > 30 points from baseline
[Time Frame: 8 weeks]
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Time to clinical response
[Time Frame: 8 weeks]
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Secondary ID(s)
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REM-1/MDA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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