Clinical trial NCT01003379 (phase 2, status: completed)
Conditions: cognitive dysfunction, schizophrenia
ICD codes: F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9
Drugs: tc-5619, placebo
SMILES: [H][C@@]1(CC2=CC=CN=C2)N2CCC(CC2)[C@@]1([H])NC(=O)C1=CC2=C(O1)C=CC=C2, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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