NCT00141947|UnknownPhase 3DMC
Bexarotene Treatment in Schizophrenia
Safety and Efficacy of Add-On Oral Bexarotene to Antipsychotic Treatment in Schizophrenia Patients: An Open Label Trial
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Sponsor study identifier
interventional
15
1 country
2
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 1, 2005
Actual (reported)September 2, 2005
Actual (reported)September 2006
Date type not reportedThis date has not been verified as actual or estimated.
Schedule for Assessment of Mental Disorder
The Positive and Negative Syndrome Scale
Montgomery and Äsberg Depression Rating Scale
Beersheva Mental Health Center
Beersheva, Israel
Shaar Manashe Mental Health Center
Hadera, Israel
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.
Vladimir Lerner, MD, PhD
Ben-Gurion University of the Negev
Michael Ritsner, MD
Technion-Israel Institute of Technology (Haifa)
First Submitted
September 1, 2005
First Posted
September 2, 2005
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
September 2006
The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia
Contact the study team to confirm eligibility.
This date has not been verified as actual or estimated.
Last Updated
July 24, 2013
Record last verified: 2005-10
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Source: ClinicalTrials.gov.
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