Overview

Aripiprazole Treatment of Bipolar Depression

Status:
Completed

Trial end date:
2006-11-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Indiana University School of Medicine

Treatments:

Aripiprazole

Criteria

Inclusion Criteria:

- 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.

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.

3) 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.

-