Aripiprazole Treatment of Bipolar Depression
Study Details
Study Description
Brief Summary
This is a study of addition of aripirazole to the treatment of bipolar depressed patients who are not better on the medications that they are currently receiving.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
Hypothesis/Objectives:
Aim 1: To investigate whether aripiprazole is effective in the treatment of bipolar depression.
Hypothesis 1: Aripiprazole will lead to a significant decrease in scores on the Hamilton Depression Rating Scale (HAM-D) during an 8-week treatment course.
- Study Population:
A total number of 10 evaluable patients will be enrolled in the study.
- Study Design and Method
This proposal will use an open label design. Aripiprazole will be added to the treatment of patients with DSM-IV (American Psychiatric Association, 1994) BDD. Patients will be allowed to continue their psychotropic medication, at a stable dose, as long as they meet inclusion criteria as described below. Aripiprazole will be started at a dose of 10 mg for two weeks, 15 mg for an additional two weeks, and 20 mg for the last four weeks. The length of time a patient stays on the maximum dose (20 mg) depends upon the patient's tolerance and treatment response. Treatment will continue for 8 weeks with weekly visits and ratings on the 17-item Hamilton Depression Rating Scale (HAM-D 17) and other ratings scales.
Study Design
Outcome Measures
Primary Outcome Measures
- Hamilton Depression Scale []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- Male or female between 18 - 65 years of age, inclusive 2) Satisfy DSM-IV criteria for bipolar disorder depressed phase i.e.,duration of depression > 2 weeks) 3) No change in psychotropic medication or their doses within 2 weeks of inclusion in The study. 4) Inadequately responsive to or intolerant of prior pharmacotherapy as determined by the investigator 5) 17-item Hamilton Depression Rating Scale Score > 15
- Young Mania Rating Scale (Young, et. al., 1978) (YMRS) < 10.
Exclusion Criteria:
Exclusion Criteria: 1) History of or currently suffering from serious medical illness, or be on medication that may interact with aripiprazole 2) On any other neuroleptic e.g., olanzapine, risperidone, ziprasidone, haloperidol.
- History of substance abuse within 3 months or substance dependence within 6 months of the study. 4) Pregnant or planning to be pregnant or not using adequate contraception. 5) Received electroconvulsive therapy (ECT) treatment in the past 1 year. 6) Significant suicide or homicide risk at the time of the study; 7) Not on any herbal or any other alternative pharmacological treatment. 8) Renal or hepatic dysfunction 9) History of decreased sweating or heat stroke.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UH 3124 University Hospital | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Indiana University School of Medicine
Investigators
- Principal Investigator: Amit Anand, MD, Indiana University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 69883
- 0402-46