drugset / Trial / NCT01338298

Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia

NCT01338298

Completed 60 enrolled University of Maryland, Baltimore
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Prolactin is a hormone that naturally occurs in the body. Some women taking antipsychotic medications may have high levels of prolactin in their bodies. High levels of prolactin may cause women to have problems with sex or satisfaction from sex. It may also cause women to have fewer or no menstrual periods. It may also cause the production of breast milk and may contribute to long term bone loss. In this study, the investigators are testing whether taking adding a low dose of an antipsychotic medication called aripiprazole may help improve high prolactin levels and help with sexual dysfunction or problems with menstrual periods. The investigators are also looking to see if it may slow the loss of bones. This medication has been shown to be helpful for improving symptoms of schizophrenia.

Timeline

Start
2011-01
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aripiprazole Other / unclassified 5 mg Oral
Comparator Aripiprazole Other / unclassified 10 mg Oral
Comparator Aripiprazole Other / unclassified 15 mg Oral

Indications