Trials / Terminated
TerminatedNCT00557427
Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression
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
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Rafa Laboratories · Industry
- Sex
- All
- Age
- 12 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | hypericum | 250mg tablets twice daily for 8 weeks |
| DRUG | fluoxetine | 20mg - 40mg daily for 8 weeks |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2007-11-14
- Last updated
- 2011-06-27
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT00557427. Inclusion in this directory is not an endorsement.