Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Targacept Inc.
Age
18–60
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
