Bipolar Depression
Conditions
Keywords
Adults, Bipolar Depression, Bipolar Disorder, Bipolar I, Bipolar II, Depression
Brief summary
The specific aim of this study is to obtain preliminary evidence of the acute effectiveness and tolerability of aripiprazole in the treatment of bipolar depression.
Interventions
DRUGaripiprazole
open label treatment with aripiprazole
Sponsors
University of Cincinnati
Lindner Center of HOPE
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* subjects must have bipolar I, II or NOS disorder as defined by DSM-IV-TR; must have clinical significant depressive symptoms and have failed one or more mood stabilizer trials; may or may not be receiving antimanic or mood stabilizing medications; subjects or legally authorized representative must sign the Informed Consent document after the nature of the trial has been fully explained; if female, subjects must be postmenopausal, surgically incapable of childbearing or practicing medically acceptable effective method(s) of contraception.
Exclusion criteria
* subjects who do not have bipolar disorder by DSM-IV criteria; subjects with current DSM-IV Axis I diagnosis of delirium, dementia, amnesia or other cognitive disorders or a psychotic disorder; subjects with serious general medical illness; subjects who are allergic to or have demonstrated hypersensitivity to aripiprazole; women who are pregnant or nursing; subjects who have received an experimental drug or used an experimental device within 30 days; subjects who have a history of neurologic malignant syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | per protocol |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression Scale Modified for Bipolar Illness (CGI-BP) | per protocol |
Countries
United States
Outcome results
None listed