Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia
Condition: Hyperprolactinemia
MeSH terms: Hyperprolactinemia; Schizophrenia
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Aripiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Symptomatic Hyperprolactinemia; Hormone; Menstrual