TC-5619 as Augmentation Therapy to Improve Cognition in Outpatients With Cognitive Dysfunction in Schizophrenia

Exclusion Criteria

• •Diagnosis of schizoaffective or schizophreniform disorders 1 year prior to Screening
• •Patients at significant risk of suicide or of danger to themselves or others
• •Antipsychotics other than quetiapine or risperidone, or a change in dosing of these within 2 months of Screening
• •Treatment with mood stabilizers, antidepressants, or anxiolytics (short-acting hypnotics permitted)
• •Treatment within 1 month using cognition-affecting agents other than the above, as listed in Appendix 3 (e.g. CNS stimulants)
• •Use of other prohibited concomitant medications
• •Other concomitant medications that have been changed within 1 month prior to Screening
• •History within past 6 months of alcohol or illicit drug abuse
• •Use of smoking cessation therapy within 1 month prior to Screening
• •Tobacco users with no detectable urine cotinine level; and tobacco non-users with a detectable urine cotinine level
• •Unable to comply with study procedures in opinion of investigator, including CogState battery
• •History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder
• •Myocardial infarction
• •Seizure disorder
• •Type 1 diabetes mellitus (DM); type 2 DM that requires medication (diet-controlled allowed, with HbA1C \< 7.3)
• •Electroconvulsive therapy within 2 months prior to Screening
• •Uncontrolled hypothyroidism, vitamin B12 or folic acid deficiency
• •Current TB or known systemic infection (HBV, HCV, HIV)
• •Clinically significant finding on physical exam that could be a safety issue in the study
• •ALT or AST levels \> 2.5 times the upper limits of the laboratory reference range
• •Clinically significant lab or ECG abnormality that could be a safety issue in the study, including QTcF \> 450msec (males) or QtcF \> 480msec (females)
• •Women of child-bearing potential and men unwilling or unable to use accepted methods of birth control
• •Women with a positive pregnancy test, or who are lactating
• •Participation in another clinical trial in last 3 months prior to Screening
• •Involvement in planning or conduct of the study by site staff