Clinical trial NCT00557427: Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Depression
Keywords: mild to moderate depression according to the DSM-IV scale
Lead sponsor: Rafa Laboratories
Sponsor class: INDUSTRY
First posted: 2007-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit
timeFrame: 8 weeks
Secondary outcomes:
measure: Percentage of patients with a decrease of CDRS-R score > 30 points from baseline
timeFrame: 8 weeks
measure: Final mean CDRS-R score
timeFrame: 8 weeks
measure: Change in CDRS-R score
timeFrame: 8 weeks
measure: Time to clinical response
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Director, child and adolescent division, Schneider Children's Hospital of Israel, Chairman Dept. of Psychiatry Sackler School of Medicine, Tel-Aviv University
name: Alan Apter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Findling RL, McNamara NK, O'Riordan MA, Reed MD, Demeter CA, Branicky LA, Blumer JL. An open-label pilot study of St. John's wort in juvenile depression. J Am Acad Child Adolesc Psychiatry. 2003 Aug;42(8):908-14. doi: 10.1097/01.CHI.0000046900.27264.2A.
citation: Simeon J, Nixon MK, Milin R, Jovanovic R, Walker S. Open-label pilot study of St. John's wort in adolescent depression. J Child Adolesc Psychopharmacol. 2005 Apr;15(2):293-301. doi: 10.1089/cap.2005.15.293.