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Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

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ClinicalTrials.gov Identifier: NCT00557427
Recruitment Status : Terminated (Lack of enrollment)
First Posted : November 14, 2007
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
Rafa Laboratories

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.

Condition or disease Intervention/treatment Phase
Depression Drug: hypericum Drug: fluoxetine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
hypericum 250mg tablets twice daily for 8 weeks
Drug: hypericum
250mg tablets twice daily for 8 weeks
Other Name: Remotiv
Active Comparator: B
fluoxetine 20mg - 40mg daily for 8 weeks
Drug: fluoxetine
20mg - 40mg daily for 8 weeks



Primary Outcome Measures :
  1. Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Percentage of patients with a decrease of CDRS-R score > 30 points from baseline [ Time Frame: 8 weeks ]
  2. Final mean CDRS-R score [ Time Frame: 8 weeks ]
  3. Change in CDRS-R score [ Time Frame: 8 weeks ]
  4. Time to clinical response [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00557427


Locations
Israel
Schneider Children's Medical Center of Israel
Petach Tikva, Israel
Sponsors and Collaborators
Rafa Laboratories
Investigators
Principal Investigator: Alan Apter, MD Director, child and adolescent division, Schneider Children's Hospital of Israel, Chairman Dept. of Psychiatry Sackler School of Medicine, Tel-Aviv University

Publications of Results:
Responsible Party: Roy L. Mellovitz, Rafa Laboratories Ltd.
ClinicalTrials.gov Identifier: NCT00557427     History of Changes
Other Study ID Numbers: REM-1/MDA
First Posted: November 14, 2007    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by Rafa Laboratories:
mild to moderate depression according to the DSM-IV scale

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors