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Bexarotene Treatment in Schizophrenia
This study is currently recruiting participants.
Verified by Beersheva Mental Health Center, October 2005
Sponsors and Collaborators: Beersheva Mental Health Center
Stanley Medical Research Institute
Information provided by: Beersheva Mental Health Center
ClinicalTrials.gov Identifier: NCT00141947
  Purpose

In this proposed study, we aim to investigate the effects of Bexarotene (Targretin; LGD1069; 4-[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl] benzoic acid) on severity of psychopathology, cognitive impairment, and quality of life in schizophrenia patients in an open label trial. The rationale behind add-on oral bexarotene to ongoing antipsychotic treatment in schizophrenia patients is based on both the retinoid dysregulation hypothesis (Goodman, 1995) and the growth factors deficiency and synaptic destabilization hypothesis (Moises et al, 2002) of schizophrenia. In this clinical trial, a novel regimen of low dose bexarotene (Targretin, 75 mg/day) will be added for 6 weeks to the standard treatment of 15 schizophrenia patients on stable antipsychotic treatment. Participants will be assessed at baseline and after 2, 4 and 6 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.


Condition Intervention Phase
Schizophrenia
 Drug: bexarotene (Targretin)
 Phase III

MedlinePlus related topics: Mental Health Schizophrenia
Drug Information available for: Bexarotene
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: Safety and Efficacy of Add-On Oral Bexarotene to Antipsychotic Treatment in Schizophrenia Patients: An Open Label Trial

Further study details as provided by Beersheva Mental Health Center:

Primary Outcome Measures:
  • Schedule for Assessment of Mental Disorder
  • The Positive and Negative Syndrome Scale
  • Montgomery and Äsberg Depression Rating Scale

Estimated Enrollment: 15
Study Start Date: September 2005
Estimated Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-60
  • schizophrenia
  • stable blood parameters
  • normal baseline fasting triglyceride
  • ability to sign informed consent

Exclusion Criteria:

  • lipid abnormalities
  • leukopenia or neutropenia
  • organic brain damage (mental retardation)
  • alcohol or drug abuse
  • renal disease
  • hepatic dysfunction
  • history of pancreatitis
  • thyroid axis alterations
  • suicide attempt in past year
  • cataracts
  • systemic treatment with more than 15,000IU vitamin A daily
  • patients with known hypersensitivity to bexarotene or other components of the product
  • pregnant women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141947

Contacts
Contact: Vladimir Lerner, MD, PhD 972-8-6401408 lernervld@yahoo.com
Contact: Chanoch Midownik, MD 972-8-6401404 chanoch_m@yahoo.com

Locations
Israel
Beersheva Mental Health Center Recruiting
Beersheva, Israel
Contact: Vladimir Lerner, MD, PhD     972-8-6401408     lernervld@yahoo.com    
Principal Investigator: Vladimir Lerner, MD, PhD            
Shaar Manashe Mental Health Center Recruiting
Hadera, Israel
Contact: Michael Ritsner, MD     9728-627-8750     ritsner@shaar-menashe.org.il    
Principal Investigator: Michael Ritsner, MD            
Sponsors and Collaborators
Beersheva Mental Health Center
Stanley Medical Research Institute
Investigators
Principal Investigator: Vladimir Lerner, MD, PhD Ben-Gurion University of the Negev
Principal Investigator: Michael Ritsner, MD Technion-Israel Institute of Technology (Haifa)
  More Information

Publications indexed to this study:
Lerner V, Miodownik C, Gibel A, Kovalyonok E, Shleifer T, Goodman AB, Ritsner MS. Bexarotene as add-on to antipsychotic treatment in schizophrenia patients: a pilot open-label trial. Clin Neuropharmacol. 2008 Jan-Feb;31(1):25-33.

Study ID Numbers: BMHC-3775
Study First Received: September 1, 2005
Last Updated: October 24, 2005
ClinicalTrials.gov Identifier: NCT00141947  
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Beersheva Mental Health Center:
bexarotene
schizophrenia
psychopathology
 cognitive impairment
quality of life
open lable trial

Study placed in the following topic categories:
Schizophrenia
Bexarotene
Mental Disorders
 Quality of Life
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
 Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009



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