Bexarotene Treatment in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Safety and Efficacy of Add-On Oral Bexarotene to Antipsychotic Treatment in Schizophrenia Patients: An Open Label Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00141947
• Other study ID #: BMHC-3775
• Status: Recruiting
• Phase: Phase 3
• First received: September 1, 2005
• Last updated: July 23, 2013
• Start date: September 2005
• Est. completion date: September 2006

Study information

• Verified date: October 2005
• Source: Beersheva Mental Health Center
• Contact: Vladimir Lerner, MD, PhD
• Phone: 972-8-6401408
• Email: lernervld[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• bexarotene (Targretin)

Locations

Country	Name	City	State
Israel	Beersheva Mental Health Center	Beersheva
Israel	Shaar Manashe Mental Health Center	Hadera

Sponsors (2)

Lead Sponsor	Collaborator
Beersheva Mental Health Center	Stanley Medical Research Institute

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Schedule for Assessment of Mental Disorder
Primary	The Positive and Negative Syndrome Scale
Primary	Montgomery and Äsberg Depression Rating Scale