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Bexarotene and Fenretinide as Addition to Antipsychotic Treatment in Schizophrenia Patients

This study has been withdrawn prior to enrollment.
(The study withdrawn due to lack financial support)
Sponsor:
Information provided by:
Beersheva Mental Health Center
ClinicalTrials.gov Identifier:
NCT00534898
First received: September 24, 2007
Last updated: June 28, 2010
Last verified: September 2007
History of Changes
  Purpose

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 Intervention Phase
Schizophrenia
Schizoaffective Disorder
Cognition
 Drug: Bexarotene
Drug: Fenretinide
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 NLM:

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

Further study details as provided by Beersheva Mental Health Center:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534898

Locations
Israel
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
Investigators
Principal Investigator: Vladimir Lerner, MD, PhD Ben-Gurion University of the Negev
Study Director: Chanoch Miodownik, MD Ben-Gurion University of the Negev
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00534898     History of Changes
Other Study ID Numbers: LMR250850MHC
Study First Received: September 24, 2007
Last Updated: June 28, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Bexarotene
Fenretinide
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antineoplastic Agents
Anticarcinogenic Agents
Protective Agents

ClinicalTrials.gov processed this record on May 21, 2013