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Bexarotene Treatment in Schizophrenia

NCT ID: NCT00141947

Last Updated: 2013-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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bexarotene (Targretin)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanley Medical Research Institute

OTHER

Sponsor Role collaborator

Beersheva Mental Health Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Vladimir Lerner

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vladimir Lerner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ben-Gurion University of the Negev

Michael Ritsner, MD

Role: PRINCIPAL_INVESTIGATOR

Technion-Israel Institute of Technology (Haifa)

Locations

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Beersheva Mental Health Center

Beersheva, , Israel

Site Status RECRUITING

Shaar Manashe Mental Health Center

Hadera, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Vladimir Lerner, MD, PhD

Role: CONTACT

[email protected]
972-8-6401408

Chanoch Midownik, MD

Role: CONTACT

[email protected]
972-8-6401404

Facility Contacts

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Vladimir Lerner, MD, PhD

Role: primary

[email protected]
972-8-6401408

Michael Ritsner, MD

Role: primary

[email protected]
9728-627-8750

References

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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.

Reference Type DERIVED
PMID: 18303488 (View on PubMed)

Other Identifiers

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BMHC-3775

Identifier Type: -

Identifier Source: org_study_id

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