Bexarotene and Fenretinide as Addition to Antipsychotic Treatment in Schizophrenia Patients
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.