Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia

Exclusion Criteria

• •1. Involuntarily committed to a psychiatric hospital or correctional facility.
• •2. A primary active DSM-IV diagnosis or co-morbid Axis 1 diagnosis other than schizophrenia or schizoaffective disorder.
• •3. PANSS Score \> than 120 at the screening visit.
• •4. Current medical diagnosis that which could confound the interpretation or evaluation of the indication under study (i.e. Parkinson's Disease, Huntington's Chorea, Muscular Dystrophy, Tourette's Syndrome).
• •5. History of liver cirrhosis, chronic active hepatitis (known positive serum test within 6 months of enrollment) or severe liver dysfunction, or liver transaminase ≥3 times ULN at screening (or obtained within 30 days prior to screening visit)
• •6. History of malignancy during the last 5 years.
• •7. Pregnant or any woman of childbearing potential who is not using a reliable form of contraception (this can include an oral or other hormonal contraceptive started at least 4 weeks prior to randomization, a barrier method such as condoms or a diaphragm used with spermicide, or an intrauterine device (IUD)). Women who have been post-menopausal for at least two years or who have undergone surgical sterilization are considered to be not of childbearing potential.
• •8. Any medical, such as unstable cardiovascular, respiratory, neurological, renal, hepatic, immunological or endocrine, or psychiatric condition which in the opinion of the investigator makes the patient an unsuitable candidate for the study.
• •9. History of any pre-existing gastrointestinal narrowing or inability to swallow the oral study medication whole with the aid of water.
• •10. Male and female patients with a BMI of ≥20.
• •11. Significant, ongoing alcohol or drug dependency within 3 months before screening as defined by the DSM-IV (nicotine will not be exclusionary).
• •12. Significant risk of suicide or violent behavior as clinically assessed by the investigator.
• •13. Participation in any other investigational drug or device study within 30 days of randomization.
• •14. Patients who have previously participated in this study.