Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia

Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia: a 6-week, Randomized, Double-blind Placebo-controlled Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00535574

Enrollment

Registered

2007-09-26

Start date

2008-11-30

Completion date

2011-05-31

Last updated

2012-07-26

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

Conditions

Schizophrenia

Keywords

retinoids, bexarotene, schizophrenia, PANSS, Positive and negative symptoms of schizophrenia

Brief 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

Detailed description

Recruiting was beginning on November 2008

Interventions

DRUGBexarotene (Targretin LGD1069)

75 mg per day for 6 weeks

DRUGbexarotene

75 mg/day 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

1. Age 18-60 years, male or female 2. DSM-IV criteria for schizophrenia, or schizoaffective disorder. 3. Ability and willingness to sign informed consent for participation in the study 4. 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. 5. 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

1. Lipid abnormalities. Fasting triglyceride normal (normalization with an antilipemic allowed prior to study entry). 2. Leucopenia or neutropenia. Hematopoietic: Hemoglobin at least 12.5 g/dL; WBC\< 4300/μL; Absolute neutrophil count \< 3000/μL; Platelet count \< 155,000/μL 3. Evidence of organic brain damage, mental retardation, alcohol or drug abuse 4. Impairment of renal function 5. Hepatic dysfunction 6. A history of pancreatitis 7. Thyroid axis alterations 8. Suicide attempt in past year. 9. Cataracts. 10. Systemic treatment with more than 15,000 IU of vitamin A daily. 11. Patients with a known hypersensitivity to bexarotene or other components of the product. 12. Pregnant women or a woman who intends to become pregnant.

Design outcomes

Primary

Measure	Time frame
PANSS, CDSS, GAF, QLS	every two weeks

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026