Bipolar Disorder
Conditions
Brief summary
Inpatient Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Mania: This study recruits adult subjects who are diagnosed with Bipolar I Disorder and presently experiencing an episode of mania. Patients must be willing to spend initial 7 days in the hospital to observe response to medication. Patients must be refractory (intolerant or non-responsive) to treatment with lithium and valproate or carbamazepine. Patients receive study-related care at no cost. This study is sponsored by Eli Lilly and Company.
Interventions
DRUGOlanzapine
Sponsors
Eli Lilly and Company
University Hospitals Cleveland Medical Center
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* The subject satisfied Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of Bipolar Disorder, most recently manic * The patient is willing to be hospitalized on an inpatient psychiatric unit for a minimum of seven (7) days. * Subject has been treated with lithium in the past. * Subject has been treated with divalproex or carbamazepine in the past. * Subject has been treated with Haldol or haloperidol in the past.
Exclusion criteria
* Subjects lacks the capacity to provide informed consent * Subject is a serious suicide risk or has medically unstable conditions as judged by the investigators * Subject has been dependent on a drug (other than nicotine or caffeine) in the last three (3) months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Young Mania Rating Scale (YMRS) | Change from Baseline to End of Study |
Countries
United States
Outcome results
None listed