Clinical trial NCT00141947: Bexarotene Treatment in Schizophrenia
Official title: Safety and Efficacy of Add-On Oral Bexarotene to Antipsychotic Treatment in Schizophrenia Patients: An Open Label Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Schizophrenia
Keywords: bexarotene
schizophrenia
psychopathology
cognitive impairment
quality of life
open lable trial
Lead sponsor: Beersheva Mental Health Center
Sponsor class: OTHER_GOV
Collaborators: name: Stanley Medical Research Institute
First posted: 2005-09-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Schedule for Assessment of Mental Disorder
measure: The Positive and Negative Syndrome Scale
measure: Montgomery and Äsberg Depression Rating Scale
Secondary outcomes:
Other outcomes:
Locations:
city: Beersheva
country: Israel
facility: Beersheva Mental Health Center
city: Hadera
country: Israel
facility: Shaar Manashe Mental Health Center
Study officials:
affiliation: Ben-Gurion University of the Negev
name: Vladimir Lerner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Technion-Israel Institute of Technology (Haifa)
name: Michael Ritsner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.