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

This is an interventional treatment trial for Cognitive Dysfunction focused on measuring cognitive dysfunction, schizophrenia, Phase 2 Read More

Inclusion Criteria:

• Diagnosis of schizophrenia, per DSM-IV TR criteria, as aided by the MINI International Neuropsychiatric Interview (MINI)
• Controlled schizophrenia, on same dose of quetiapine or risperidone for no less than 2 months prior to screening
• Age 18 - 60, male or female
• Stable schizophrenia as documented by lack of psychiatric hospitalization for 2 months prior to Screening
• Clinical history of stable psychotic symptoms for 1 month prior to Screening
• Stable positive symptoms of schizophrenia for 4 weeks prior to Day 1, as shown by score ≤ 4 on PANSS for items related to delusion, hallucination, conceptual disorganization, and unusual thought content, at Screening and at Day 1
• Calgary Depression Scale for Schizophrenia score < 6
• Outpatient with stable housing, and presence of an informant who sees the subject at least 4 times weekly
• Able to understand and sign informed consent

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