A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety and tolerability of licarbazepine 750-2500 mg/d combined with risperidone in the treatment of manic episodes of bipolar I disorder over 6 weeks

• Conditions: Bipolar I disorder, manic and mixed episodes

• Registration Number: EUCTR2004-000113-18-HU
• Lead Sponsor: ovartis Hungaria Kft.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 430

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

•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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified