Hyperprolactinemia Clinical Trial
Official title:
Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia
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.
This will be a 16-week, double blind, placebo controlled randomized trial of aripiprazole
added to an existing stabilized regimen of antipsychotics (either risperidone or paliperidone
oral or long acting injectable formulations) for treatment of elevated symptomatic prolactin
levels. 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. Women will remain
on their current stabilized medication regimen during the course of the adjunctive trial of
aripiprazole or placebo. Subjects will be able to receive anticholinergic medications as
needed (e.g., benztropine and diphenhydramine) for extrapyramidal side effects, propranolol
for akathisia, and benzodiazepines (e.g.,lorazepam) for agitation or anxiety.
Participants will be assigned to either get aripiprazole or placebo (a sugar pill), this will
be decided randomly with a 50-50 chance of receiving one or the other medication. 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. The dosing will be the
exact same, one capsule taken daily until week 8. At this time 2 capsules will be given if
the participant dose not regains their menstrual period.
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