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Hypericum vs Fluoxetine for Mild to Moderate Adolescent Depression

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by:
Rafa Laboratories
ClinicalTrials.gov Identifier:
NCT00557427
First received: November 13, 2007
Last updated: June 23, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Depression
 Drug: hypericum
Drug: fluoxetine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Rafa Laboratories:

Primary Outcome Measures:
  • Rate of clinical response (defined by CDRS-R < 28) at the final/withdrawal visit [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with a decrease of CDRS-R score > 30 points from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Final mean CDRS-R score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in CDRS-R score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Time to clinical response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Roy L. Mellovitz, Rafa Laboratories Ltd.
ClinicalTrials.gov Identifier: NCT00557427     History of Changes
Other Study ID Numbers: REM-1/MDA, REM-1/MDA
Study First Received: November 13, 2007
Last Updated: June 23, 2011
Health Authority: Israel: Ministry of Health

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
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013