NCT00141947

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_3 schizophrenia

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2005

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

July 24, 2013

Status Verified

October 1, 2005

First QC Date

September 1, 2005

Last Update Submit

July 23, 2013

Conditions

Schizophrenia

Keywords

bexaroteneschizophreniapsychopathologycognitive impairmentquality of lifeopen lable trial

Outcome Measures

Primary Outcomes (3)

  • Schedule for Assessment of Mental Disorder

  • The Positive and Negative Syndrome Scale

  • Montgomery and Äsberg Depression Rating Scale

Interventions

bexarotene (Targretin)DRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beersheva Mental Health Center

Beersheva, Israel

RECRUITING

Shaar Manashe Mental Health Center

Hadera, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 18303488DERIVED

MeSH Terms

Conditions

SchizophreniaCognitive Dysfunction

Interventions

Bexarotene

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersCognition DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

TetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Vladimir Lerner, MD, PhD

    Ben-Gurion University of the Negev

    PRINCIPAL INVESTIGATOR

  • Michael Ritsner, MD

    Technion-Israel Institute of Technology (Haifa)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladimir Lerner, MD, PhD

CONTACT

972-8-6401408lernervld@yahoo.com

Chanoch Midownik, MD

CONTACT

972-8-6401404chanoch_m@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

September 1, 2005

Study Completion

September 1, 2006

Last Updated

July 24, 2013

Record last verified: 2005-10

Locations

IL(2)