Sarizotan in the Treatment of Neuroleptic-induced Tardive Dyskinesia

Exclusion Criteria

• •Evidence of pre-existing tic disorders, neuroleptic-induced acute dystonia or neuroleptic-induced acute akathisia
• •Risk of suicide (in the opinion of the investigator).
• •Any of the following non-permitted concomitant medication: Metoclopramide in the 4 weeks before screening, Buspirone in the 4 weeks before screening, Azole antifungals (particularly ketoconazole), Etomidate, HIV proteinase inhibitors (e.g. indinavir, ritonavir), any tricyclic antidepressant in the 4 weeks before screening (SSRI antidepressants if at a stable dosage are permitted), Fludrocortisone, Intermittent therapy with oral corticoids, continuous therapy with \<7.5mg/day (oral) prednisolone or an equivalent dose of a different corticoid (patients on continuous long-term therapy with a dose of \>7.5mg prednisolone or equivalent may participate but should not undergo an ACTH challenge test).
• •Treatment with electroconvulsive therapy within six months before the first study visit.
• •Known history of drug dependence (except nicotine and caffeine) or alcohol dependence within the six months before the study (three months for known drug abuse).
• •Evidence of any clinically significant endocrine, cardiac, renal, neurological, cerebrovascular, metabolic, gastrointestinal, immunological, allergic or respiratory disease. Patients who are not euthyroid.
• •asthma or known hypersensitivity to antipsychotic drugs or ACTH
• •Pregnancy or lactation.
• •Any abnormal laboratory test result(s) of potential clinical significance at screening, including: Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) greater than 3 ´ upper limit of normal (ULN), Creatinine \>2 ´ ULN, total bilirubin \>2 ´ ULN
• •Participation in another clinical study within the 30 days before the first visit of the present study.
• •Plasma cortisol concentration below 18 µg/dL 60 minutes after stimulation with 250 µg ACTH1-24 (for procedure see Section 7.9). (NOTE: This exclusion criterion is waived, and the test should not be carried out, for patients on continuous long-term therapy with a dose of \>7.5mg prednisolone or equivalent.
• •Lack of legal capacity, or limited legal capacity.)
• •Known previous diagnosis of learning disability.