Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

Rafa Laboratories

Status and phase

Terminated

Phase 4

Conditions

Depression

Treatments

Drug: fluoxetine

Drug: hypericum

Study type

Interventional

Funder types

Industry

Identifiers

NCT00557427

REM-1/MDA

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

12 to 18 years old

Volunteers

No 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