Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia

Exclusion Criteria

• •1. Diagnosis of schizoaffective or schizophreniform disorders within 1 year prior to Screening.
• •2. Significant risk of suicide or attempted suicide in the 12 months before screening, or of danger to themselves or others.
• •3. Change in dosing of atypical antipsychotic within 2 months of Screening.
• •4. Treatment with electroconvulsive therapy (ECT) within 12 months of Screening.
• •5. Treatment with mood stabilizers, antidepressants, anxiolytics (short-acting hypnotics permitted), anticholinergics, or more than 1 antipsychotic within 1 month prior to Screening.
• •6. Treatment within 1 month prior to Screening with cognition-affecting agents other than the above (e.g. CNS stimulants).
• •7. History within past 6 months of screening of alcohol or illicit drug abuse.
• •8. Use of smoking cessation therapy within 1 month prior to Screening.
• •9. Positive urine drug screen except when related to prescribed short-acting benzodiazepines and opiates recently prescribed for an episode of acute pain (e.g., dental extraction).
• •10. History of significant other major or unstable neurological, neurosurgical (e.g. head trauma), metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder.
• •11. History of myocardial infarction based on medical history or electrocardiogram (ECG) findings at screening.
• •12. History of seizure disorder.
• •13. Type 1 diabetes mellitus.
• •14. Type 2 diabetes mellitus that requires medication (diet-controlled allowed, with HbA1C \< 7.3).
• •15. Body Mass Index (BMI) \> 35.
• •16. Uncontrolled hypothyroidism, vitamin B12 or folic acid deficiency.
• •17. Current TB or known systemic infection (e.g., HBV, HCV, HIV).
• •18. Clinically significant lab or ECG abnormality that could be a safety issue in the study, including QTcF \> 450 for males and \>470 for females.
• •19. Men, or women of child-bearing potential, who are unwilling or unable to use accepted methods of birth control as specified in Section 4.4.4
• •20. Women with a positive pregnancy test, or who are lactating.
• •21. Participated in another clinical trial within 3 months prior to Screening.