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Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00535574
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : July 26, 2012
Information provided by (Responsible Party):
Vladimir Lerner, Beersheva Mental Health Center

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 ( 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 or disease Intervention/treatment Phase
Schizophrenia Drug: Bexarotene (Targretin LGD1069) Drug: bexarotene Phase 3

Detailed Description:
Recruiting was beginning on November 2008

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : November 2008
Primary Completion Date : December 2010
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Bexarotene
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. PANSS, CDSS, GAF, QLS [ Time Frame: every two weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00535574

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
Principal Investigator: Prof. Vladimir Lerner, MD, PhD Be'er Sheva Mental Health Center Ben Gurion University of the Negev

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vladimir Lerner, A/Professor, Head of department, Beersheva Mental Health Center Identifier: NCT00535574     History of Changes
Other Study ID Numbers: LRM250850
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: July 26, 2012
Last Verified: May 2011

Keywords provided by Vladimir Lerner, Beersheva Mental Health Center:
Positive and negative symptoms of schizophrenia

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents