None listed
Conditions
Interventions
GROUP 1 Type of group
Selection Phase: Duration of 28 days. During this phase the patients will have a pharmacological wash of the prohibited medications. They should also start with a dose of Valproate or Lithium that allows them to maintain an adequate therapeutic concentration (Lithium 0.6-1-2 mmol / l and Valproate: 50-125 ug / ml).
Pre-Randomization Phase: Duration of 7 days. All patients will maintain the stable dose of lithium or valproate established in the selection phase.
Double Blind Treatment Phase:
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Young Mania Classification Scale (Y-MRS). Measure:Change from the baseline to the final point in the total score of the Y-MRS scale score. Timepoints:Week 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Response to treatment: Evaluation of the response to treatment, which is defined as the reduction from baseline to the final point of the Y-MRS scale score of at least 50%. 2) Rate of responders: Evaluation to determine the percentage of patients that reach a response to treatment. 3) Application of the Brief Psychiatric Classification Scale (BPRS). 4) Application of the Clinical Anxiety Scale (CAS). 5) Application of the Hamilton Depression Rating Scale (HAMD). 6) Application of the Classification of the Global Improvement of Clinical Global Impression (GGI-1). Measure:Secondary efficacy: 1) Response to treatment. 2) Rate of respondents. 3) Change from the baseline to the final point in the BPRS scale. 4) Change from the baseline to the final point in the CAS scale. 5) Change from the baseline to the final point on the HAMD scale. 6) Value of GGI-1. Timepoints:Week 6. ; Outcome name:1) Adverse events: Evaluation of the appearance or worsening of any sign, symptom or undesirable medical condition that occurs after starting the study drug, even if the event is not considered related to the study drug. The degree of severity, its relationship with the study drug, the action taken against it and whether it is a serious adverse event will be evaluated. 2) Physical examination: Evaluation of the general appearance, ears, eyes, nose, pharynx, lungs, heart, abdomen, back, thyroid, lymph nodes, and nervous system. 3) Laboratory tests: Hematology and serum chemistry panels, urine analysis 4) ECG: standard 12-lead ECG. All ECG assessments will be done in the morning and at least 2 hours after the last meal. 5) Vital Signs: Body temperature, systolic and diastolic blood pressure, radial pulse, weight and height. Measurements of systolic and diastolic blood pressure and radial pulse should be taken after the patient has been sitting 5 minutes. 6) Special tests: IgM-HepA, Anit-HBsAb, Anti-HbcAb, T3, T4, TSH, | — |
Countries
Austria, Canada, Colombia, Czech Republic, Germany, Guatemala, Peru, Russian Federation, Slovakia, South Africa, Ukraine, United States, Venezuela
Outcome results
None listed