CTRI/2009/091/001040已完成2 期
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
TargaceptInc0 个研究点目标入组 185 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 185
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 18 - 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
- •1. Diagnosis of schizoaffective or schizophreniform disorders 1 year prior to Screening
- •2. Patients at significant risk of suicide or of danger to themselves or others
- •3. Antipsychotics other than quetiapine or risperidone, or a change in dosing of these within 2 months of Screening
- •4. Treatment with mood stabilizers, antidepressants, or anxiolytics (short-acting hypnotics permitted)
- •5. Treatment within 1 month using cognition-affecting agents other than the above, as listed in Appendix 3 (e.g.
- •CNS stimulants)
- •6. Use of other prohibited concomitant medications
- •7. Other concomitant medications that have been changed within 1 month prior to Screening
- •8. History within past 6 months of alcohol or illicit drug abuse
- •9. Use of smoking cessation therapy within 1 month prior to Screening
- •10. 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)
- •11. Unable to comply with study procedures in opinion of investigator, including CogState battery
- •12. History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary,
- •cardiovascular, gastrointestinal, or urological disorder
- •13. History of myocardial infarction
- •14. History of seizure disorder
- •15. Type 1 diabetes mellitus (DM); type 2 DM that requires medication (diet-controlled allowed, with HbA1C < 7.3)
- •16. Electroconvulsive therapy within 2 months prior to Screening
- •17. Uncontrolled hypothyroidism, vitamin B12 or folic acid deficiency
- •18. Current TB or known systemic infection (HBV, HCV, HIV)
- •19. Clinically significant finding on physical exam that could be a safety issue in the study
- •20. ALT or AST levels > 2.5 times the upper limits of the laboratory reference range
- •21. Clinically significant lab or ECG abnormality that could be a safety issue in the study, including QTcF > 450
- •(males) or QTcF > 480msec (females)
- •22. Women of child-bearing potential and men unwilling or unable to use accepted methods of birth control
- •23. Women with a positive pregnancy test, or who are lactating
- •24. Participation in another clinical trial in last 3 months prior to Screening
- •25. Involvement in planning or conduct of the study by site staff
- •26. Body Mass Index (BMI) < 15 and > 31 without prior approval from the medical monitor
研究者
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