Bexarotene and Fenretinide as Addition to Antipsychotic Treatment in Schizophrenia Patients

NCT00534898 | Withdrawn Phase 3 DMC

• 1 other identifier: LMR250850MHC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Background: In this proposed study, we aim to investigate safety and efficacy of two synthetic retinoids - bexarotene (Targretin; LGD1069; 4-\[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl\] benzoic acid) and fenretinide (Dihydroceramide N-(4-Hydroxyphenyl retinamide) on severity of psychopathology and cognitive impairment in schizophrenia patients in an double-blind, placebo-controlled study. The rationale behind add-on these medications to ongoing antipsychotic treatment in schizophrenia patients is based on both the retinoid dysregulation hypothesis: the growth factors deficiency and synaptic destabilization hypothesis of schizophrenia. Furthermore, in our preliminary open clinical trial, we found that a low dose of bexarotene (Targretin, 75 mg/day) was safe and led to significant improvement on total PANSS scores, general psychopathology, on the positive and the dysphoric mood factor scores. The aim of the present study was to provide further insight into the safety and efficacy of bexarotene in comparison to fenretinide (a medication with smaller potential of adverse effects) and placebo in patients suffered from schizophrenia.

Conditions

Schizophrenia; Schizoaffective Disorder; Cognition

Interventions

Bexarotene DRUG

Fenretinide DRUG

Placebo DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years, male or female
• DSM-IV criteria for schizophrenia
• Ability and willingness to sign informed consent for participation in the study
• Stable blood parameters
• Only patients who had a normal baseline fasting triglyceride

You may not qualify if:

• Lipid abnormalities.
• Leukopenia or neutropenia.
• Evidence of organic brain damage, mental retardation, alcohol or drug abuse
• Renal disease
• Hepatic dysfunction.
• A history of pancreatitis.
• Thyroid axis alterations
• Suicide attempt in past year.
• Cataracts.
• High dose of vitamin A daily treatment.
• Patients with a known hypersensitivity to bexarotene or other components of the product.
• Pregnant women or a woman who intends to become pregnant.

Sponsors & Collaborators

• Beersheva Mental Health Center: lead

Study Sites (1)

Be'er Sheva Mental Health Center, Sha'ar Menashe Mental Health Center

Be'er Sheva, Hadera, 84170, Israel

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Bexarotene; Fenretinide

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Vladimir Lerner, MD, PhD

  Ben-Gurion University of the Negev

  PRINCIPAL INVESTIGATOR

• Chanoch Miodownik, MD

  Ben-Gurion University of the Negev

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 24, 2007
• First Posted: September 26, 2007
• Last Updated: June 29, 2010

Record last verified: 2007-09

Locations

IL (1)