Overview

The Monitor of Serum Prolactin Level in a 3 Months Aripiprazole Trial

Status:
Unknown status
Trial end date:
2007-07-01
Target enrollment:
0
Participant gender:
All
Summary
A short term post-market monitoring of serum prolactin level change among patients with schizophrenia shifting from other antispychotics to different dosages of aripiprazole.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yu-Li Hospital
Treatments:
Aripiprazole
Criteria
Inclusion Criteria:

Patients may be included in the study if they meet the following criteria:

1. Males and females 16-65 years of age

2. Diagnosis of schizophrenia, schizoaffective or schizophreniform disorder

3. Each individual must have a level of understanding sufficient to perform all tests and
examinations required

4. Individuals must be willing to fast after midnight the evening prior to study visit

5. Individuals must be willing to provide a small sample of blood for evaluation

6. Individuals must be willing to participate in a short 30-45 minute clinical interview

Exclusion Criteria:

Patients may be excluded from the study for any of the following reasons:

1. A current diagnosis of diabetes mellitus

2. Serious unstable illness such that death is anticipated within 1 year or intensive
care unit hospitalization for the condition is anticipated within 6 months

3. Uncorrected hypothyroidism or hyperthyroidism

4. Uncorrected tumor secreting ectopic prolactinemia