A Clinical Trial to study the Effect of TC-5619 as Augmentation Therapy to Improve Cognition in Outpatients With Cognitive Dysfunction in Schizophrenia.
- Conditions
- Health Condition 1: null- Cognitive Dysfunction in Schizophrenia
- Registration Number
- CTRI/2009/091/001040
- Lead Sponsor
- TargaceptInc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 185
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method