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Bexarotene Treatment in Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Beersheva Mental Health Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Beersheva Mental Health Center
ClinicalTrials.gov Identifier:
NCT00141947
First received: September 1, 2005
Last updated: October 24, 2005
Last verified: October 2005
History of Changes

September 1, 2005
October 24, 2005
September 2005
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  • Schedule for Assessment of Mental Disorder
  • The Positive and Negative Syndrome Scale
  • Montgomery and Äsberg Depression Rating Scale
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Complete list of historical versions of study NCT00141947 on ClinicalTrials.gov Archive Site
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Bexarotene Treatment in Schizophrenia
Safety and Efficacy of Add-On Oral Bexarotene to Antipsychotic Treatment in Schizophrenia Patients: An Open Label Trial

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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
Drug: bexarotene (Targretin)
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
September 2006
Not Provided

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
Both
18 Years to 60 Years
No
Contact: Vladimir Lerner, MD, PhD 972-8-6401408 lernervld@yahoo.com
Contact: Chanoch Midownik, MD 972-8-6401404 chanoch_m@yahoo.com
Israel
 
NCT00141947
BMHC-3775
Not Provided
Not Provided
Beersheva Mental Health Center
Stanley Medical Research Institute
Principal Investigator: Vladimir Lerner, MD, PhD Ben-Gurion University of the Negev
Principal Investigator: Michael Ritsner, MD Technion-Israel Institute of Technology (Haifa)
Beersheva Mental Health Center
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP