Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-11-30

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.

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Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

hypericum 250mg tablets twice daily for 8 weeks

Group Type EXPERIMENTAL

hypericum

Intervention Type DRUG

250mg tablets twice daily for 8 weeks

B

fluoxetine 20mg - 40mg daily for 8 weeks

Group Type ACTIVE_COMPARATOR

fluoxetine

Intervention Type DRUG

20mg - 40mg daily for 8 weeks

Interventions

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hypericum

250mg tablets twice daily for 8 weeks

Intervention Type DRUG

fluoxetine

20mg - 40mg daily for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Remotiv

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Rafa Laboratories Ltd.

Principal Investigators

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Alan Apter, MD

Role: PRINCIPAL_INVESTIGATOR

Director, child and adolescent division, Schneider Children's Hospital of Israel, Chairman Dept. of Psychiatry Sackler School of Medicine, Tel-Aviv University