CClinicalTrials.gg
Status unknownNCT00141947Updated Jul 24, 2013

Bexarotene Treatment in Schizophrenia

A Phase 3 interventional study of bexarotene (Targretin) in Schizophrenia, sponsored by Beersheva Mental Health Center. Status unknown at 2 sites in Israel. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-07-24.

Sponsored by Beersheva Mental Health Center · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2005), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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.

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Conditions studied

  • Schizophrenia

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Keywords

  • bexarotene
  • schizophrenia
  • psychopathology
  • cognitive impairment
  • quality of life
  • open lable trial
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In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's planned enrollment of 15 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Beersheva Mental Health Center is the lead sponsor of 24 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age 18-60
  • schizophrenia
  • stable blood parameters
  • normal baseline fasting triglyceride
  • ability to sign informed consent

Exclusion criteria

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Interventions

  • Drugbexarotene (Targretin)
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What researchers measure

Primary outcomes

  1. Schedule for Assessment of Mental Disorder

  2. The Positive and Negative Syndrome Scale

  3. Montgomery and Äsberg Depression Rating Scale

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Study locations

2 of 2 sites recruiting
  • Beersheva Mental Health Center
    Beersheva, Israel
    • Vladimir Lerner, MD, PhD · Contact · lernervld@yahoo.com · 972-8-6401408
    • Vladimir Lerner, MD, PhD · Principal investigator
    Recruiting
  • Shaar Manashe Mental Health Center
    Hadera, Israel
    Recruiting
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References and documents

Publications

  • 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. PubMed 18303488 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00141947
Lead sponsor
Beersheva Mental Health Center
Collaborators
Stanley Medical Research Institute
Responsible party
Vladimir Lerner (Associated Professor, Beersheva Mental Health Center) — Principal investigator
First posted
Sep 2, 2005
Start date
Sep 2005
Completion
Sep 2006
Last update
Jul 24, 2013

Study contacts

Vladimir Lerner, MD, PhD
Contact
lernervld@yahoo.com
972-8-6401408
Chanoch Midownik, MD
Contact
chanoch_m@yahoo.com
972-8-6401404
Vladimir Lerner, MD, PhD
principal investigator · Ben-Gurion University of the Negev
Michael Ritsner, MD
principal investigator · Technion-Israel Institute of Technology (Haifa)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2005. You cannot join it, but the record below documents what was studied.

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