Bexarotene and Fenretinide as Addition to Antipsychotic Treatment in Schizophrenia Patients

June 28, 2010 updated by: Beersheva Mental Health Center

Comparison Efficacy of Bexarotene and Fenretinide as Addition to Antipsychotic Treatment in Schizophrenia Patients: Double-blind Placebo Controlled Study

Background: In this proposed study, we aim to investigate safety and efficacy of two synthetic retinoids - bexarotene (Targretin; LGD1069; 4-[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl] benzoic acid) and fenretinide (Dihydroceramide N-(4-Hydroxyphenyl retinamide) on severity of psychopathology and cognitive impairment in schizophrenia patients in an double-blind, placebo-controlled study. The rationale behind add-on these medications to ongoing antipsychotic treatment in schizophrenia patients is based on both the retinoid dysregulation hypothesis: the growth factors deficiency and synaptic destabilization hypothesis of schizophrenia. Furthermore, in our preliminary open clinical trial, we found that a low dose of bexarotene (Targretin, 75 mg/day) was safe and led to significant improvement on total PANSS scores, general psychopathology, on the positive and the dysphoric mood factor scores. The aim of the present study was to provide further insight into the safety and efficacy of bexarotene in comparison to fenretinide (a medication with smaller potential of adverse effects) and placebo in patients suffered from schizophrenia.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

In this clinical trial, a minimal dose of bexarotene (Targretin, 75 mg/day) or fenretinide 5 mg/day or placebo will be added for 8 weeks to the stable ongoing antipsychotic treatment of 90 schizophrenia patients. Participants will be assessed at baseline and after 2, 4 and 8 weeks of treatment. A battery of research instruments will be used for assessment of efficacy and safety (psychopathology, and side effects). In addition, cholesterol and triglyceride levels, liver and thyroid function tests and a blood cell count will be monitored at baseline and during therapy.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Be'er Sheva, Hadera, Israel, 84170
        • Be'er Sheva Mental Health Center, Sha'ar Menashe Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-60 years, male or female
  2. DSM-IV criteria for schizophrenia
  3. Ability and willingness to sign informed consent for participation in the study
  4. Stable blood parameters
  5. Only patients who had a normal baseline fasting triglyceride

Exclusion criteria:

  1. Lipid abnormalities.
  2. Leukopenia or neutropenia.
  3. Evidence of organic brain damage, mental retardation, alcohol or drug abuse
  4. Renal disease
  5. Hepatic dysfunction.
  6. A history of pancreatitis.
  7. Thyroid axis alterations
  8. Suicide attempt in past year.
  9. Cataracts.
  10. High dose of vitamin A daily treatment.
  11. Patients with a known hypersensitivity to bexarotene or other components of the product.
  12. Pregnant women or a woman who intends to become pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beersheva Mental Health Center

Investigators

  • Study Director: Chanoch Miodownik, MD, Ben-Gurion University of the Negev

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 24, 2007

First Submitted That Met QC Criteria

September 24, 2007

First Posted (Estimate)

September 26, 2007

Study Record Updates

Last Update Posted (Estimate)

June 29, 2010

Last Update Submitted That Met QC Criteria

June 28, 2010

Last Verified

September 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMR250850MHC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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