Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
- Conditions
- -F31F31
- Registration Number
- PER-070-06
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. Men and women from 18 to 70 years of age.
2. Diagnosis of type I bipolar disorder, manic or mixed manic episodes.
3. Score at least 20 on the Young Mania Rating Scale (YMRS).
4. Necessity of psychiatric treatment.
5. Cooperation and desire to complete all aspects of the study.
6. Written informed consent provided before participation in the study.
1. Another current diagnosis different from bipolar I disorder.
2. History of schizophrenia or schizoaffective disorder.
3. Concomitant use of psychoactive medication other than lorazepam, lithium or valproate.
4. Drug dependence during the month prior to the selection.
5. Positive urine drug in the screening visit for amphetamines, cocaine, hallucinogens, or opiates.
6. History of attempted suicide within one month before the screening visit or immediate risk of harm to self or others at the time of selection.
7. Mental retardation according to the DSM-IV criteria.
8. Female patients with potential to become pregnant who are not using effective contraception during the study, are breastfeeding or have a positive pregnancy test (B-hCG) in the selection or at baseline.
9. Serum sodium ≤ 130 mmol / L basal or history of multiple episodes of hyponatremia.
10. Any sensory or motor deficit that could prevent the patient from completing any evaluation of the study.
11. Any non-psychiatric coexisting disease that has not been maintained in a stable condition for at least 3 months prior to baseline.
12. Abnormal clinically significant conditions of the gastrointestinal system, liver, or kidneys that could produce the possibility of alterations of absorption, excess of accumulation, or alteration of the metabolism or excretion of the drug.
13. Twice above the upper limit of normal in the selection with repeated measurements of the following laboratory parameters: SGOT, SGPT, LDH, alkaline phosphatase, or bilirubin; BUN values ≥ 30 mg / dL or creatinine clearance <30 mL / min.
14. Any other abnormal clinical laboratory finding that is significant in the selection that continues abnormal after repeated measurements.
15. Any of the following serological findings: a) Hepatitis A positive antibody (IgM). b) Hepatitis B surface antigen (HBsAg) positive. c) Hepatitis B central antibody (Anti-HBcAb) positive, together with a negative surface antigen of hepatitis B (Anti-HBsAb), in case of abnormal liver enzymes or recent symptoms of hepatitis.
16. History of past or recent diagnosis of epilepsy, major head trauma, or progressive neurological disease.
17. Known hypersensitivity to lithium or valproate or related drugs
chemically with licarbazepine.
18. Exhibition for 30 days before selection to any drug not registered for the country where the study is being conducted.
19. Electroconvulsive therapy (ECT) within 3 months before baseline.
20. Any form of psychotherapy within the month preceding the selection.
21. Hospitalization due to mania due to a court order.
22. Patients under supervision or legal guardianship.
23. Previous treatment in any study with licarbazepine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Young Mania Classification Scale (Y-MRS).<br>Measure:Change from the baseline to the final point in the total score of the Y-MRS scale score.<br>Timepoints:Week 6.<br>
- Secondary Outcome Measures
Name Time Method