Bipolar Disorder
Conditions
Keywords
Bipolar I Disorder, Mania, Memantine HCl
Brief summary
Bipolar disorder affects 2.4 million adults in the USA between the ages of 18-65 and has considerable economic impact on our society. Bipolar mania accounts for 1 in 7 psychiatric emergencies and is associated with significant morbidity and mortality. The purpose of the study is to evaluate the safety and efficacy of open-label memantine in the acute management of adults with bipolar I disorder hospitalized for mania.
Interventions
DRUGMemantine HCl
Sponsors
Forest Laboratories
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have a documented clinical diagnosis of bipolar I disorder and must be currently experiencing a manic or mixed episode. * Patients must be voluntarily hospitalized with a primary diagnosis of mania.
Exclusion criteria
* Rapid cycling bipolar disorder. * Suicidal risk. * First manic episode. * ECT, clozapine or a depot neuroleptic in the past 3 months. * Substance dependence. * Known HIV infection. * Co-morbid serious, uncontrolled systemic illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Young Mania Rating Scale (YMRS) | — |
| Mania Rating Scale | — |
| Clinical Global Impression | — |
| Montgomery Asberg Depression Rating Scale | — |
| Positive and Negative Syndrome Scale (PANSS) | — |
| PANSS - Excited Component | — |
Countries
United States
Outcome results
None listed