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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00557427

Enrollment

Registered

2007-11-14

Start date

2009-01-31

Completion date

2010-11-30

Last updated

2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

mild to moderate depression according to the DSM-IV scale

Brief 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.

Interventions

DRUGhypericum

250mg tablets twice daily for 8 weeks

DRUGfluoxetine

20mg - 40mg daily for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026