Acute and maintenance treatment of schizophrenia and manic episodes associated with bipolar I disorder. MedDRA version: 8.1 Level: LLT Classification code 10039626 Term: Schizophrenia
Conditions
Interventions
Product Name: Asenapine
Product Code: Org 5222
Pharmaceutical Form: Tablet
INN or Proposed INN: asenapine
CAS Number: 85650-56-2
Current Sponsor code: Org 5222
Concentration unit: mg milligram(s)
Conc
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General Inclusion Criteria: Subjects should: 1. be male or female subjects, 65 years of age or greater. 2. willing to sign written informed consent (subjects unable or incapable of signing may participate if the legally authorized representative provides consent and the subject affirms their participation). 3. be fluent in the language of the investigator, and study staff (including raters) and informed consent 4. have a caregiver or an identified responsible person (eg, family member, social worker, caseworker or nurse) considered reliable by the investigator in providing support to the subject to ensure compliance with study treatment, outpatient visits, and protocol procedures. Diagnoses Subjects should: 1. have psychotic symptoms as evidenced by a score of 4 or more on at least 1 of the following PANSS items: P1 Delusions P3 Hallucinatory behavior P4 Excitement P7 Hostility G14 Poor Impulse Control 2. have a minimum PANSS total score >50 at screening. 3. have a Clinical Global Impression – Severity of Illness (CGI S) scale score of at least 3 at screening. Pre-trial medication Subjects should: 1. have responded positively to an antipsychotic medication other than clozapine (Clozaril®). 2. have discontinued depot neuroleptics prior to first dose (Day 1) (last dose of depot neuroleptics should be received more than 1 dosing interval minus 1 week prior to first dose). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects should be excluded from the trial if they: Psychiatric Exclusion Criteria 1. have current (within 6 months prior to screening) DSM IV TR™ defined substance abuse/dependence (excluding nicotine and caffeine). 2. have an established diagnosis of delirium according to DSM IV TR™ criteria. 3. are at imminent risk of self-harm or are at risk of harming to others. 4. have a score of 2 on any of items 7,10, or 11 on the Modified InterSePT scale for suicidal thinking (ISST). 5. have a score of 17 or below on Mini Mental State Examination (MMSE). Medical Exclusion Criteria 1. have an uncontrolled, unstable clinically significant medical condition (eg, renal, hepatic, endocrine, respiratory, cardiovascular, metabolic, hematologic, immunologic, cerebrovascular disease, anorexia or obesity [body mass index (BMI) = 18.5 or >35] or malignancy), which, in the opinion of the investigator, may interfere with the interpretation of safety, efficacy, or pharmacokinetic evaluations. In case of BMI beyond the limits mentioned above, discussion should occur between the investigator and the sponsor before enrolling such subject(s) in the study. 2. have jaundice or total bilirubin of >2X upper limit of normal (ULN). 3. have any clinically significant abnormal laboratory, vital signs, physical examination, or electrocardiogram (ECG) findings at screening and any significant changes at randomization that, in the opinion of the investigator, precludes trial participation. 4. have narrow angle glaucoma. 5. have a seizure disorder beyond childhood or are taking any anticonvulsants to prevent seizures. 6. have known serological evidence of HIV antibody. 7. have a history of neuromalignant syndrome in the past 5 years. 8. have a life-time history of cerebrovascular accident (e.g., documented history of stroke or TIA’s). 9. have a history of myocardial infarction in past 5 years. 10. have Parkinson’s disease. Medications 1. have been judged by the principal investigator to be medically noncompliant in the management of their disease. 2. have been judged by the principal investigator to be unable to reduce his or her daily benzodiazepine intake during inpatient phase to a maximum of 6 mg/day of lorazepam (or the equivalent dose of another short-acting benzodiazepine). 3. have been treated with clozapine in the previous 6 months; 4. have previously participated in an asenapine clinical trial. 5. have taken an investigational drug within 30 days prior to first dose (Day 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the safety and tolerability 6-weeks of asenapine up to doses of 10 mg BID in elderly subjects with psychosis. • To evaluate the pharmacokinetics of multiple dose administration of asenapine up to doses of 10 mg BID in elderly subjects with psychosis. ;Secondary Objective: • To explore the pharmacokinetic/pharmacodynamic relationship of asenapine in elderly subjects with psychosis. • To characterize tolerability of the 2 titration schedules. ;Primary end point(s): There are not primary endpoints per se as there would be in an efficacy study. This is purely a safety study. Detailed methodology for summary and statistical analysis will be found in the Statistical Analysis Plan. Sample Size Determination 120 subjects with a 20% drop out rate will likely yield exposure data on 100 elderly subjects Pharmacokinetic/pharmacodynamic modeling analysis - The relationship between asenapine exposure and PANSS and CGI-S scores will be investigated - Pharmacokinetic parameters such as Cmax, tmax, and AUC will be estimated from plasma concentration-time data - Descriptive statistics will be used to analyze concomitant medications, adverse events, changes in ESRS-A, lab values, and vital signs parameters | — |
Countries
Czech Republic
Outcome results
None listed