Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia
Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
Summary
Background: Bexarotene (Targretin) is a synthetic retinoid mainly used for treatment of
patients suffer from oncological or dermatological diseases. The present study is based on:
evidence that retinoids are involved in neurodevelopment ("the retinoid dysregulation
hypothesis"); an assumption that the combined effect of antipsychotic agents and bexarotene
will have a beneficial effect on schizophrenia patients; and the positive findings from our
pilot open-label clinical trial (ClinicalTrials.gov Identifier: NCT00141947). However,
clinical efficacy of bexarotene should be investigated in a placebo-controlled trial.
Methods: In a 6-week, randomized, double-blind placebo-controlled trial Targretin (75 mg/day)
or placebo capsules will be added to the stable ongoing antipsychotic treatment of 90
schizophrenia patients. 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
psychopathology, side effects, general functioning and quality of life. In addition,
cholesterol and triglyceride levels, liver and thyroid function tests and a blood cell count
will be monitored at baseline and during the study