Bexarotene Treatment in Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Beersheva Mental Health Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Vladimir Lerner, Beersheva Mental Health Center
ClinicalTrials.gov Identifier:
NCT00141947
First received: September 1, 2005
Last updated: July 23, 2013
Last verified: October 2005
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: bexarotene (Targretin)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Add-On Oral Bexarotene to Antipsychotic Treatment in Schizophrenia Patients: An Open Label Trial

Resource links provided by NLM:


Further study details as provided by Beersheva Mental Health Center:

Primary Outcome Measures:
  • Schedule for Assessment of Mental Disorder
  • The Positive and Negative Syndrome Scale
  • Montgomery and Äsberg Depression Rating Scale

Estimated Enrollment: 15
Study Start Date: September 2005
Estimated Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141947

Contacts
Contact: Vladimir Lerner, MD, PhD 972-8-6401408 lernervld@yahoo.com
Contact: Chanoch Midownik, MD 972-8-6401404 chanoch_m@yahoo.com

Locations
Israel
Beersheva Mental Health Center Recruiting
Beersheva, Israel
Contact: Vladimir Lerner, MD, PhD    972-8-6401408    lernervld@yahoo.com   
Principal Investigator: Vladimir Lerner, MD, PhD         
Shaar Manashe Mental Health Center Recruiting
Hadera, Israel
Contact: Michael Ritsner, MD    9728-627-8750    ritsner@shaar-menashe.org.il   
Principal Investigator: Michael Ritsner, MD         
Sponsors and Collaborators
Beersheva Mental Health Center
Stanley Medical Research Institute
Investigators
Principal Investigator: Vladimir Lerner, MD, PhD Ben-Gurion University of the Negev
Principal Investigator: Michael Ritsner, MD Technion-Israel Institute of Technology (Haifa)
  More Information

No publications provided by Beersheva Mental Health Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vladimir Lerner, Associated Professor, Beersheva Mental Health Center
ClinicalTrials.gov Identifier: NCT00141947     History of Changes
Other Study ID Numbers: BMHC-3775
Study First Received: September 1, 2005
Last Updated: July 23, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Beersheva Mental Health Center:
bexarotene
schizophrenia
psychopathology
cognitive impairment
quality of life
open lable trial

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Bexarotene
Anticarcinogenic Agents
Antineoplastic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014