Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vladimir Lerner, Beersheva Mental Health Center
ClinicalTrials.gov Identifier:
NCT00535574
First received: September 24, 2007
Last updated: July 25, 2012
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Bexarotene (Targretin LGD1069)
Drug: bexarotene
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia: a 6-week, Randomized, Double-blind Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Beersheva Mental Health Center:

Primary Outcome Measures:
  • PANSS, CDSS, GAF, QLS [ Time Frame: every two weeks ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: November 2008
Study Completion Date: May 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Bexarotene (Targretin LGD1069) Drug: Bexarotene (Targretin LGD1069)
75 mg per day for 6 weeks
Drug: bexarotene
75 mg/day 6 weeks
Active Comparator: placebo Drug: Bexarotene (Targretin LGD1069)
75 mg per day for 6 weeks

Detailed Description:

Recruiting was beginning on November 2008

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00535574

Locations
Israel
Be'er Sheva Mental Health Center
Be'er Sheva,, Be'er Sheva, Israel, 84170
Abarbanel Mental Health Center
Bat-Yam, Israel
Sha'ar Menashe Mental Health Center,
Hadera,, Israel
Sponsors and Collaborators
Beersheva Mental Health Center
Investigators
Principal Investigator: Prof. Vladimir Lerner, MD, PhD Be'er Sheva Mental Health Center Ben Gurion University of the Negev
  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, A/Professor, Head of department, Beersheva Mental Health Center
ClinicalTrials.gov Identifier: NCT00535574     History of Changes
Other Study ID Numbers: LRM250850
Study First Received: September 24, 2007
Last Updated: July 25, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Beersheva Mental Health Center:
retinoids
bexarotene
schizophrenia
PANSS
Positive and negative symptoms of schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Bexarotene
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2014