Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia

NCT ID: NCT00535574

Last Updated: 2012-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-05-31

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

Conditions

Schizophrenia

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Bexarotene (Targretin LGD1069)

Group Type: PLACEBO_COMPARATOR

Bexarotene (Targretin LGD1069)

Intervention Type: DRUG

75 mg per day for 6 weeks

bexarotene

Intervention Type: DRUG

75 mg/day 6 weeks

placebo

Group Type: ACTIVE_COMPARATOR

Bexarotene (Targretin LGD1069)

Intervention Type: DRUG

75 mg per day for 6 weeks

Interventions

Bexarotene (Targretin LGD1069)

75 mg per day for 6 weeks

Intervention Type: DRUG

bexarotene

75 mg/day 6 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beersheva Mental Health Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Vladimir Lerner

A/Professor, Head of department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof. Vladimir Lerner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Be'er Sheva Mental Health Center Ben Gurion University of the Negev

Locations

Be'er Sheva Mental Health Center

Beersheba, Be'er Sheva, Israel

Abarbanel Mental Health Center

Bat Yam, , Israel

Sha'ar Menashe Mental Health Center,

Hadera, , Israel

Countries

Israel

References

Lerner V, Miodownik C, Gibel A, Sirota P, Bush I, Elliot H, Benatov R, Ritsner MS. The retinoid X receptor agonist bexarotene relieves positive symptoms of schizophrenia: a 6-week, randomized, double-blind, placebo-controlled multicenter trial. J Clin Psychiatry. 2013 Dec;74(12):1224-32. doi: 10.4088/JCP.12m08160.

Reference Type: DERIVED

PMID: 24434091 (View on PubMed)

Other Identifiers

LRM250850

Identifier Type: -

Identifier Source: org_study_id