Aripiprazole Treatment of Bipolar Depression

Completed · Phase 4

Conditions studied: Bipolar Depression

In brief

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.

Key facts

Study ID: NCT00198198
Run by: Indiana University
People needed: 10
Starts: 2005-08-01
Expected to finish: 2006-11-01
Last updated by the study team: 2007-04-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

1) 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 6) Young Mania Rating Scale (Young, et. al., 1978) (YMRS) < 10.

You may not qualify if…

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.

Where it is running

UH 3124 University Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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