Bexarotene and Fenretinide as Addition to Antipsychotic Treatment in Schizophrenia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00534898
Recruitment Status : Withdrawn (The study withdrawn due to lack financial support)
First Posted : September 26, 2007
Last Update Posted : June 29, 2010
Information provided by:
Beersheva Mental Health Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Cognition Drug: Bexarotene Drug: Fenretinide Drug: Placebo Phase 3

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  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Efficacy of Bexarotene and Fenretinide as Addition to Antipsychotic Treatment in Schizophrenia Patients: Double-blind Placebo Controlled Study

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Bexarotene
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All

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.

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 identifier (NCT number): NCT00534898

Be'er Sheva Mental Health Center, Sha'ar Menashe Mental Health Center
Be'er Sheva, Hadera, Israel, 84170
Sponsors and Collaborators
Beersheva Mental Health Center
Principal Investigator: Vladimir Lerner, MD, PhD Ben-Gurion University of the Negev
Study Director: Chanoch Miodownik, MD Ben-Gurion University of the Negev Identifier: NCT00534898     History of Changes
Other Study ID Numbers: LMR250850MHC
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: June 29, 2010
Last Verified: September 2007

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents