Bipolar I Disorder MedDRA version: 8.0 Level: LLT Classification code 10004939
Conditions
Sponsors
N V Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for the trial, subjects must: Demographic 1. Be a male, or a female who is not of childbearing potential (i.e., surgically sterile, postmenopausal for at least 1 year); or nonpregnant using a method of birth control that is acceptable to the investigator, and not breastfeeding; Procedural 2. Have completed Trial A7501008 without major protocol violation; 3. Sign written informed consent after the scope and nature of the investigation have been explained to them before registration evaluations. Subjects unable or incapable of signing may participate if a legal representative provides consent and the subject affirms their participation; 4. Have a caregiver or an identified responsible person (e.g., family member, social worker, case worker, or nurse) considered reliable by the investigator in providing support to the subject to ensure compliance with trial treatment, outpatient visits, and protocol procedures; and Trial medication 5. Be willing to abstain from psychotropic rescue medications, except for the allowable anticholinergic agents, beta-blockers, benzodiazepines, and antidepressants as specified in the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: Potential participants will be excluded from the trial if they have: Medical status 1. An uncontrolled, unstable, clinically significant medical condition (eg, renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease, or malignancy), that, in the opinion of the investigator, may interfere with the interpretation of safety and efficacy. 2. Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings identified during the registration process and which, in the investigator’s opinion, preclude the subject’s participation in the trial (interfere with the ability to evaluate safety, tolerability, and efficacy of trial medication or impair completion of the trial as a result of non-medication related medical complications); 3. A positive result of the serum pregnancy test at registration (prospective subject and investigator will be notified), or the intent to become pregnant during the course of the trial. 4. Narrow angle glaucoma. 5. A seizure disorder beyond childhood or the taking of an anticonvulsant(s) to prevent seizures. 6. Known serological evidence of human immunodeficiency virus (HIV) antibody. Psychiatric 7. An imminent risk of self-harm as defined by an ISST (modified) score of 2 on item 7, 10, or 11 at registration, or harm to others. Medication 8. Been judged by the investigator to be medically non-compliant in the management of his/her disease. 9. Been judged by the investigator to be unable to completely avoid the use of psychotropic medications, with the exception of anti-cholinergic agents, beta-blockers, benzodiazepines, and anti-depressants as specified in the protocol. 10. A known allergy or hypersensitivity to asenapine; or 11. Been unable to discontinue any excluded medication(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or VPA for the treatment of an acute manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008. The safety comparison will be between the group receiving lithium or VPA and placebo against the group receiving lithium or VPA and asenapine, with the caveat that all subjects may receive benzodiazepine and/or antidepressant rescue medication as needed. A primary efficacy objective of this trial is to characterize the long-term maintenance of effect of asenapine on Young-Mania rating scale (Y-MRS) and Montgomery-Asberg Depression Rating Scale (MADRS) scores, after the initial 12 weeks of treatment (in the A7501008 lead-in trial) with adjunctive therapy.;Secondary Objective: Evaluating the long-term adjunctive treatment effects of asenapine compared to placebo with respect to: · Overall clinical impression of severity of, and improvement in, mania, depression, and overall bipolar state · Depression · Psychotic symptoms · Anxiety · Readiness to discharge · Quality of life · Cognitive function · Suicidal thinking · Safety and tolerability [including extrapyramidal symptoms (EPS)];Primary end point(s): The primary objective of this trial is to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or VPA for the treatment of an acute manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008. The safety comparison will be between the group receiving lithium or VPA and placebo against the group receiving lithium or VPA and asenapine, with the caveat that all subjects may receive benzodiazepine and/or antidepressant rescue medication as needed. A primary | — |
Countries
Czech Republic
Outcome results
None listed