Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia

Recruiting was beginning on November 2008

Inclusion criteria

• Age 18-60 years, male or female
• DSM-IV criteria for schizophrenia, or schizoaffective disorder.
• Ability and willingness to sign informed consent for participation in the study
• Stable blood parameters including adequate hematologic function, defined as WBC ≥ 4.300/μL, absolute neutrophil count ≥3.000/μL (> 50%), and platelet count ≥ 180,000/μL; normal coagulation parameters; bilirubin ≤1.5 times the upper limit of normal (ULN); AST/ALT ≤ 2.5 × ULN; and serum creatinine ≤1.5 mg/dL.
• Only patients who had a normal baseline fasting triglyceride (FTG) level will be entered into the study; triglycerides may be normalized before study entry with use of an antilipemic agent.

Exclusion criteria

• Lipid abnormalities. Fasting triglyceride normal (normalization with an antilipemic allowed prior to study entry).
• Leucopenia or neutropenia. Hematopoietic: Hemoglobin at least 12.5 g/dL; WBC< 4300/μL; Absolute neutrophil count < 3000/μL; Platelet count < 155,000/μL
• Evidence of organic brain damage, mental retardation, alcohol or drug abuse
• Impairment of renal function
• Hepatic dysfunction
• A history of pancreatitis
• Thyroid axis alterations
• Suicide attempt in past year.
• Cataracts.
• Systemic treatment with more than 15,000 IU of vitamin A daily.
• Patients with a known hypersensitivity to bexarotene or other components of the product.
• Pregnant women or a woman who intends to become pregnant.