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

September 24, 2007
July 25, 2012
November 2008
December 2010   (final data collection date for primary outcome measure)
PANSS, CDSS, GAF, QLS [ Time Frame: every two weeks ] [ Designated as safety issue: Yes ]
PANSS, CDSS, GAF, QLS [ Time Frame: every two weeks ]
Complete list of historical versions of study NCT00535574 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia
Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia: a 6-week, Randomized, Double-blind Placebo-controlled Trial

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

Recruiting was beginning on November 2008

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Schizophrenia
  • Drug: Bexarotene (Targretin LGD1069)
    75 mg per day for 6 weeks
  • Drug: bexarotene
    75 mg/day 6 weeks
  • Placebo Comparator: Bexarotene (Targretin LGD1069)
    Interventions:
    • Drug: Bexarotene (Targretin LGD1069)
    • Drug: bexarotene
  • Active Comparator: placebo
    Intervention: Drug: Bexarotene (Targretin LGD1069)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
May 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00535574
LRM250850
Yes
Vladimir Lerner, Beersheva Mental Health Center
Beersheva Mental Health Center
Not Provided
Principal Investigator: Prof. Vladimir Lerner, MD, PhD Be'er Sheva Mental Health Center Ben Gurion University of the Negev
Beersheva Mental Health Center
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP