Bipolar Disorder
Conditions
Keywords
bipolar disorder, manic episode, treatment, licarbazepine
Brief summary
The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional treatment with either lithium or valproate, which are already FDA (Food and Drug Administration)-approved treatments for mania.
Interventions
DRUGLicarbazepine
DRUGPlacebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of bipolar disorder (type I) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling) * In need of psychiatric treatment * Cooperation and willingness to complete all aspects of the study
Exclusion criteria
* Current diagnosis other than bipolar I disorder * History of schizophrenia or schizoaffective disorder * Drug dependence within 1 month prior to study start or testing positive in a urine drug test * Suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others * Any form of psychotherapy within 1 month prior to study start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6). | — |
Secondary
| Measure | Time frame |
|---|---|
| Major improvement in anxiety and depression from baseline to endpoint (week 6) | — |
Countries
Austria, Canada, Colombia, Czechia, Germany, Guatemala, Peru, Russia, Slovakia, South Africa, Ukraine, United States, Venezuela
Outcome results
None listed