Bexarotene Treatment in Schizophrenia

Safety and Efficacy of Add-On Oral Bexarotene to Antipsychotic Treatment in Schizophrenia Patients: An Open Label Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00141947

Enrollment

Registered

2005-09-02

Start date

2005-09-30

Completion date

2006-09-30

Last updated

2013-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

bexarotene, schizophrenia, psychopathology, cognitive impairment, quality of life, open lable trial

Brief summary

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.

Interventions

DRUGbexarotene (Targretin)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
Schedule for Assessment of Mental Disorder	—
The Positive and Negative Syndrome Scale	—
Montgomery and Äsberg Depression Rating Scale	—

Countries

Israel

Contacts

Primary ContactVladimir Lerner, MD, PhD

lernervld@yahoo.com972-8-6401408

Backup ContactChanoch Midownik, MD

chanoch_m@yahoo.com972-8-6401404

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026