Bexarotene Treatment in Schizophrenia

Beersheva Mental Health Center

Status and phase: Unknown; Phase 3

Conditions: Schizophrenia

Treatments: Drug: bexarotene (Targretin)

Study type: Interventional

Funder types: Other

Identifiers

NCT00141947

BMHC-3775

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)