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

NCT01338298 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-09-27

Study results available
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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.

Conditions

  • Hyperprolactinemia

Interventions

DRUG

Aripiprazole

Aripiprazole dosing will begin at 5 mg/day once daily and increased to 10mg by mouth once daily at the end of week 2 and then increased to 15 mg/day once daily at the end of week 8 in women who have not yet regained their menstrual period. If a woman gets her menstrual period on the 5 or 10 mg dose she will remain on this dose for the study.

DRUG

Placebo

The placebo will be sucrose filled capsules that are identical to the active medication. It is double blind so no one will know if the capsule is placebo or aripiprazole.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Deanna L Kelly, Pharm.D., BCPP · University of Maryland, College Park

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01338298 on ClinicalTrials.gov