Bipolar I disorder, manic and mixed episodes
Conditions
Interventions
Product Name: Licarbazepina
Product Code: LIC477D
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Licarbazepina
Concentration unit: mg milligram(s)
Concentration type: range
Concentration
Sponsors
Novartis Farmacéutica, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • males and females 18 through 70 years of age; • diagnosis of bipolar disorder type I, manic or mixed episode according to DSM-IV criteria (i.e., 296.0, 296.4 or 296.6), including patients with/without psychotic features or with/without a history of rapid cycling; • total score of at least 20 on the Young Mania Rating Scale (Y-MRS); • need of psychiatric treatment; 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: • current DSM-IV Axis-I diagnosis other than bipolar I disorder; • history of schizophrenia or schizoaffective disorder; • concomitant use of psychoactive medication other than risperidone and lorazepam, whereby the time between the last dose of prior medication and the baseline visit is dependent on the medication; • drug dependence during the one month prior to screening. Drug dependence is defined by DSM-IV criteria; • positive urine drug screen at screening visit for amphetamines, cocaine, hallucinogens or opiates; • history of suicide attempt within the month prior to the screening visit or immediate risk of harm to self or others at the time of screening, as judged by the Investigator; • mental retardation (according to DSM-IV criteria); • female patients of childbearing potential who are not using effective contraception during the study, are breast feeding, or have a positive pregnancy test (? hCG) at screening or baseline; • any non-psychiatric coexistent illness (e.g., diabetes mellitus, hypothyroidism) that has not been maintained in a stable condition for at least 3 months prior to baseline; • clinically significant abnormal conditions of the gastrointestinal system, liver, or kidneys, which could result in the possibility of altered absorption, excess accumulation, or impairment of metabolism or excretion of the study drug; • twice the upper normal limit at screening and upon repeated measurement for any one of the following laboratory parameters: SGOT, SGPT, LDH, alkaline phosphatase, or bilirubin BUN values ? 30 mg/dL or creatinine clearance < 30 ml/min; • any other clinically significant abnormal laboratory findings at screening which remain abnormal upon repeated measurement; • any of the following serological findings: - a positive hepatitis A antibody (IgM); - a positive hepatitis B surface antigen (HBsAg); - a positive hepatitis B core antibody (Anti-HBcAb), along with a negative hepatitis B surface antibody (Anti-HBsAb), in the setting of abnormal liver enzymes or recent clinical symptoms of hepatitis (within the last 2 months); • current diagnosis or recent past history of epilepsy, major head trauma, or progressive neurological disease (e.g., Parkinson’s disease, ALS); • electroconvulsive therapy (ECT) within the one months preceding baseline; • any form of psychotherapy within the one month preceding baseline;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of licarbazepine 750-2500 mg/d combined with risperidone in the treatment of manic episodes of bipolar I disorder by testing the following hypothesis: Licarbazepine combined with risperidone is superior to placebo combined with risperidone in the reduction of the mean total score of the Young Mania Rating Scale (Y-MRS) from baseline to endpoint (Week 6). ;Secondary Objective: 1) To study the safety and tolerability of licarbazepine 750-2500 mg/d combined with risperidone in patients with manic episodes of bipolar I disorder by comparing licarbazepine combined with risperidone to placebo combined with risperidone with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs during the 6-week treatment. 2) To determine the efficacy of licarbazepine 750-2500 mg/d combined with risperidone in the treatment of manic episodes of bipolar I disorder by testing the following hypothesis: Licarbazepine combined with risperidone is superior to placebo combined with risperidone in the proportion of patients with a ?50% reduction of the baseline Y-MRS at endpoint. ;Primary end point(s): Efficacy: The primary efficacy variable is the change from baseline to endpoint (Week 6) in the total score of the Y-MRS. Safety: The assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of pre-determined ranges. Other safety data (e.g. electrocardiogram, vital signs, and special tests) will be analyzed when appropriate. | — |
Countries
Finland, Hungary, Spain
Outcome results
None listed