A Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study to Assess Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Cognition in Outpatients with Cognitive Dysfunction in Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 12
- 主要终点
- ?To assess the efficacy of TC-5619 as augmentation therapy to quetiapine or risperidone, to improve cognition in stable outpatients with Cognitive Dysfunction in Schizophrenia (CDS), using the CogState Schizophrenia Test Battery (CSTB).
研究概览
简要总结
This is a multi-center, double blind, randomized, placebo-controlled, parallel group, study that will be conducted in five centers in the US and in twelve centers India. No more than 200 subjects will be enrolled in the study (to ensure 120 complete) with 50% of the subjects being tobacco users and 50% being non-tobacco users. In India up to 150 subjects will be enrolled in the study. Screening of subjects for the study in India is expected to start from first week of January 2010 and enrollment of the first subject in India is expected to be from the first week of February 2010 as there is a 4-week screening period before enrollment in the study. Since there is no approved treatment for CDS, a placebo-controlled study is appropriate. There will be 3 phases of the study: Screening (Week -4 to Day 1); Treatment (Day 1 - Week 12); and Follow-up (Week 12- Week 14). Primary Outcome Measures: ?To assess the efficacy of TC-5619 as augmentation therapy to quetiapine or risperidone, to improve cognition in stable outpatients with Cognitive Dysfunction in Schizophrenia (CDS), using the CogState Schizophrenia Test Battery (CSTB). [ Time Frame: Day 1 - Week 4; Week 4 - Week 8; and finally Week 8 - Week 12. There will be a 2-week follow-up period following the end of the treatment period. ] Secondary Outcome Measures: ?Assess the efficacy, safety and tolerability of TC-5619 administered adjunctively with quetiapine or risperidone, evaluate the pharmacokinetics of TC-5619 and plasma levels of quetiapine and risperidone/9-OH-risperidone. [ Time Frame: Day 1 - Week 4; Week 4 - Week 8; and finally Week 8 - Week 12. There will be a 2-week follow-up period following the end of the treatment period. ]
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosis of schizophrenia, per DSM-IV TR criteria, as aided by the MINI International Neuropsychiatric Interview (MINI) 2.Controlled schizophrenia, on same dose of quetiapine or risperidone for no less than 2 months prior to screening 3.Age
- •60, male or female 4.Stable schizophrenia as documented by lack of psychiatric hospitalization for 2 months prior to Screening 5.Clinical history of stable psychotic symptoms for 1 month prior to Screening 6.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 7.Calgary Depression Scale for Schizophrenia score < 6 8.Outpatient with stable housing, and presence of an informant who sees the subject at least 4 times weekly 9.Able to understand and sign informed consent.
排除标准
- •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 > than 50ng/mL (urine cotinine level between 50ng/ml and 500ng/ml will be excluded)
- •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
- •History of myocardial infarction
- •History of seizure disorder
- •Type 1 diabetes mellitus (DM); type 2 DM that requires medication (diet-controlled allowed, with HbA1C < 7.3)
- •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 > 450 (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
- •Involvement in planning or conduct of the study by site staff
- •Body Mass Index (BMI) < 15 and > 31 without prior approval from the medical monitor.
结局指标
主要结局
?To assess the efficacy of TC-5619 as augmentation therapy to quetiapine or risperidone, to improve cognition in stable outpatients with Cognitive Dysfunction in Schizophrenia (CDS), using the CogState Schizophrenia Test Battery (CSTB).
时间窗: Time Frame: Day 1 - Week 4; Week 4 - Week 8; and finally Week 8 - Week 12. There will be a 2-week follow-up period following the end of the treatment period.
次要结局
- ?Assess the efficacy, safety and tolerability of TC-5619 administered adjunctively with quetiapine or risperidone, evaluate the pharmacokinetics of TC-5619 and plasma levels of quetiapine and risperidone/9-OH-risperidone.(Time Frame: Day 1 - Week 4; Week 4 - Week 8; and finally Week 8 - Week 12. There will be a 2-week follow-up period following the end of the treatment period.)