Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

Study Overview
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Brief Summary
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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.

Official 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

Conditions
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Depression

Intervention / Treatment
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* Drug: hypericum
* Drug: fluoxetine


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>hypericum 250mg tablets twice daily for 8 weeks | Drug: hypericum<br>* 250mg tablets twice daily for 8 weeks<br>* Other names: Remotiv;|
| Active Comparator: B<br>fluoxetine 20mg - 40mg daily for 8 weeks | Drug: fluoxetine<br>* 20mg - 40mg daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with a decrease of CDRS-R score > 30 points from baseline |  | 8 weeks | 
| Final mean CDRS-R score |  | 8 weeks | 
| Change in CDRS-R score |  | 8 weeks | 
| Time to clinical response |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild to moderate depression according to the DSM-IV scale