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Bexarotene Treatment in Schizophrenia

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
bexarotene (Targretin)
Sponsored by
Beersheva Mental Health Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring bexarotene, schizophrenia, psychopathology, cognitive impairment, quality of life, open lable trial

Eligibility Criteria

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

Sites / Locations

  • Beersheva Mental Health CenterRecruiting
  • Shaar Manashe Mental Health CenterRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 1, 2005
Last Updated
July 23, 2013
Sponsor
Beersheva Mental Health Center
Collaborators
Stanley Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00141947
Brief Title
Bexarotene Treatment in Schizophrenia
Official Title
Safety and Efficacy of Add-On Oral Bexarotene to Antipsychotic Treatment in Schizophrenia Patients: An Open Label Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beersheva Mental Health Center
Collaborators
Stanley Medical Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
bexarotene, schizophrenia, psychopathology, cognitive impairment, quality of life, open lable trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bexarotene (Targretin)
Primary Outcome Measure Information:
Title
Schedule for Assessment of Mental Disorder
Title
The Positive and Negative Syndrome Scale
Title
Montgomery and Äsberg Depression Rating Scale

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir Lerner, MD, PhD
Phone
972-8-6401408
Email
lernervld@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chanoch Midownik, MD
Phone
972-8-6401404
Email
chanoch_m@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Lerner, MD, PhD
Organizational Affiliation
Ben-Gurion University of the Negev
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Ritsner, MD
Organizational Affiliation
Technion-Israel Institute of Technology (Haifa)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beersheva Mental Health Center
City
Beersheva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Lerner, MD, PhD
Phone
972-8-6401408
Email
lernervld@yahoo.com
First Name & Middle Initial & Last Name & Degree
Vladimir Lerner, MD, PhD
Facility Name
Shaar Manashe Mental Health Center
City
Hadera
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Ritsner, MD
Phone
9728-627-8750
Email
ritsner@shaar-menashe.org.il
First Name & Middle Initial & Last Name & Degree
Michael Ritsner, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
18303488
Citation
Lerner V, Miodownik C, Gibel A, Kovalyonok E, Shleifer T, Goodman AB, Ritsner MS. Bexarotene as add-on to antipsychotic treatment in schizophrenia patients: a pilot open-label trial. Clin Neuropharmacol. 2008 Jan-Feb;31(1):25-33. doi: 10.1097/WNF.0b013e31806450da.
Results Reference
derived

Learn more about this trial

Bexarotene Treatment in Schizophrenia

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