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Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 3

Locations

Israel

Study Type

Interventional

Intervention

Bexarotene (Targretin LGD1069)

bexarotene

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring retinoids, bexarotene, schizophrenia, PANSS, Positive and negative symptoms of schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

Be'er Sheva Mental Health Center
Abarbanel Mental Health Center
Sha'ar Menashe Mental Health Center,

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Bexarotene (Targretin LGD1069)

placebo

Arm Description

Outcomes

Primary Outcome Measures

PANSS, CDSS, GAF, QLS

Secondary Outcome Measures

Full Information

NCT ID

NCT00535574

First Posted

September 24, 2007

Last Updated

July 25, 2012

Sponsor

Beersheva Mental Health Center

1. Study Identification

Unique Protocol Identification Number

NCT00535574

Brief Title

Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beersheva Mental Health Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bexarotene (Targretin LGD1069)

Arm Type

Placebo Comparator

Arm Title

placebo

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Bexarotene (Targretin LGD1069)

Intervention Description

75 mg per day for 6 weeks

Intervention Type

Drug

Intervention Name(s)

bexarotene

Intervention Description

75 mg/day 6 weeks

Primary Outcome Measure Information:

Title

PANSS, CDSS, GAF, QLS

Time Frame

every two weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-60 years, male or female DSM-IV criteria for schizophrenia, or schizoaffective disorder. Ability and willingness to sign informed consent for participation in the study 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. 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: Lipid abnormalities. Fasting triglyceride normal (normalization with an antilipemic allowed prior to study entry). Leucopenia or neutropenia. Hematopoietic: Hemoglobin at least 12.5 g/dL; WBC< 4300/μL; Absolute neutrophil count < 3000/μL; Platelet count < 155,000/μL Evidence of organic brain damage, mental retardation, alcohol or drug abuse Impairment of renal function Hepatic dysfunction A history of pancreatitis Thyroid axis alterations Suicide attempt in past year. Cataracts. Systemic treatment with more than 15,000 IU of vitamin A daily. Patients with a known hypersensitivity to bexarotene or other components of the product. Pregnant women or a woman who intends to become pregnant.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof. Vladimir Lerner, MD, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Be'er Sheva Mental Health Center

City

Be'er Sheva,

State/Province

Be'er Sheva

ZIP/Postal Code

84170

Country

Israel

Facility Name

Abarbanel Mental Health Center

City

Bat-Yam

Country

Israel

Facility Name

Sha'ar Menashe Mental Health Center,

City

Hadera,

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

24434091

Citation

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.

Results Reference

derived

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Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia

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