Schizophrenia
Conditions
Interventions
Product Name: TC-5619
Product Code: TC-5619-23
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TC-5619-23-CRD-003
CAS Number: 1111941-90-2
Current Sponsor code: TC-5619-23
Concentration u
Sponsors
Targacept Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of schizophrenia, per Diagnostic and Statistical Manual of Disorders, Edition 4, Text Revision (DSM-IV-TR) criteria, as aided by the MINI International Neuropsychiatric Interview (MINI). 2. Controlled schizophrenia, on a stable dose of an approved atypical antipsychotic for at least 2 months prior to screening.Screening through Day 1. Approved refers to regulatory approval in the country of use. and as indicated in Appendix 2. 3. Age 18 – 60, male or female 4. Stable schizophrenia as documented by a lack of psychiatric hospitalization for 2 months prior to Screening through Day 1 (social admissions for the convenience of the subject allowed). 5. Clinical history of stable psychotic symptoms for 1 month prior to Screening through Day 1. 6. Stable positive symptoms of schizophrenia for 4 weeks prior to Day 1, as shown by score = 4 on the Positive and Negative Symptoms Scale (PANSS) for each of the items related to delusion, hallucination, conceptual disorganization, and unusual thought content, at Screening and at Day 1. 7. Sum > 20 for the 7 negative symptom items of the PANSS. 8. The subjects does not have major depressive disorder or a history of major depressive disorder for 6 months prior to screening, and a Calgary depression Schizophrenia Scale (CDSS) score =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Diagnosis of schizoaffective or schizophreniform disorders within 1 year prior to Screening through Day 1. 2. Significant risk of suicide or attempted suicide in the 12 months before screeningScreening through Day 1, or of danger to self or others. 3. A change in dosing of atypical antipsychotic within 2 months of Screening through Day 1. 4. Treatment with electroconvulsive therapy within 12 months of Screening through Day 1. 5. Treatment with mood stabilizers, antidepressants except as noted below, anxiolytics (short-acting anxiolytic/hypnotics permitted), and anticholinergics per Appendix 2 within 1 month prior to Screening through Day 1, or more than 1 antipsychotic per Appendix 2 within 2 months prior to Screening through Day 1. The use of one antidepressant is allowed if all of the following are true: a. The antidepressant has been stable for at least 3 months prior to Screening, continues to be stable through the Screening period, and the dose is not anticipated to change during the study. b. The antidepressant is a second-generation antidepressant as indicated in Appendix 2- item 2.b. 6. Treatment within 1 month prior to Screening through Day 1 with cognition-affecting agents other than the above, as listed in Appendix 2 (e.g. CNS stimulants). 7. Use of other prohibited concomitant medications as indicated in Appendix 2. 8. Other concomitant medications that have been changed within 1 month prior to Screening through Day 1. Changes in concomitant medications during this period are permitted, with approval of a medical monitor, for acute or mild conditions such as colds, seasonal allergies, temporary analgesic use, and similar conditions if the subject is clinically stable and the concomitant medication is not restricted elsewhere in the protocol. 9. History within past 6 months of screeningScreening of alcohol or illicit drug abuse, or alcohol or illicit drug abuse from Screening to Day 1. 10. Use of smoking cessation therapy within 1 month prior to Screening through Day 1. 11. The subject has a positive urine drug screen except when related to prescribed short-acting benzodiazepines and opiates recently prescribed for an episode of acute pain (e.g., dental extraction). 12. Unable to comply with study procedures in opinion of Investigator, including CogState battery. 13. History of significant other major or unstable neurological, neurosurgical (e.g. head trauma), metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder. 14. History of myocardial infarction based on medical history or electrocardiogram (ECG) findings at screening and Day 1. 15. History of seizure disorder. 16. Type 1 diabetes mellitus. 17. Type 2 diabetes mellitus that either requires medication (diet-controlled allowed, withinsulin or an HbA1C 7.3).5. 18. Body mass index (BMI) > 35.40 (applies at Screening visit only). 19. Uncontrolled hypothyroidism, vitamin B12 or folic acid deficiency. 20. Current tuberculosis (TB) or known systemic infection (e.g. HBV, HCV, HIV). 21. Clinically significant finding on physical exam that could be a safety issue in the study. 22. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 2.5 times the upper limits of the laboratory reference range. (only applicable at screening). 23. Clinically significant lab or ECG abnormality that could be a safety issue in the study, including QTcF > 450 for males and > 4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of TC-5619 to improve negative symptoms and cognition when used as augmentation therapy to atypical antipsychotics in stable outpatients with schizophrenia ;Secondary Objective: 1. To assess the safety and tolerability of TC-5619 administered adjunctively with atypical antipsychotics 2. To assess the disposition of TC-5619 and investigate pharmacokinetic/ pharmacodynamic (PK/PD) relationships.;Primary end point(s): Primary efficacy endpoint - SANS total score, comparing TC-5619 vs. placebo from Baseline (Day 1) to Week 24 or Early Withdrawal (EW) as a function of Treatment.;Timepoint(s) of evaluation of this end point: - SANS Total Score Week -4, Day 1, Week 4, 8, 12, 18, 24, 26 (Follow Up) or Early Withdrawal (EW) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints are: - The CogState Schizophrenia Battery (CSB) composite score, - University of San Diego (UCSD) Performance Based Skills Assessment, brief version (UPSA-Brief). Secondary efficacy endpoints are: - Subject Global Impression – Cognition (SGI-Cog) scale; - Clinical Global Impression of Severity (CGI-S); - Clinical Global Impression-Global Improvement (CGI-I); - PANSS total score; - Positive Symptoms score from PANSS; Other Endpoints (for tobacco users only) are: - Tobacco use: - Fagerström Test for Nicotine Dependence score (FTND): - PK Endpoint ;Timepoint(s) of evaluation of this end point: Timepoints as per protocol for various tests i.e Week -4, Day 1, Week 4, Week 8, Week 12, Week 18, Week 24 or Early Withdrawal, Week 26 (Follow up) | — |
Countries
Hungary, Romania, Russian Federation, Serbia, Ukraine, United States
Contacts
Public ContactKirill Vasilyev
Worldwide Clinical Trials Inc.
Outcome results
None listed