Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia
Information source: University of Maryland
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperprolactinemia
Intervention: Aripiprazole (Drug); Placebo (Drug)
Sponsored by: University of Maryland
Official(s) and/or principal investigator(s):
Deanna L Kelly, Pharm.D., BCPP, Principal Investigator, Affiliation: University of Maryland
Ann Kearns, Phone: 410-402-6854, Email: firstname.lastname@example.org
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.
Official title: Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To determine if adjunct aripiprazole will resolve or improve prolactin related hormonal side effects (amenorrhea, oligomenorrhea, galactorrhea).
To test whether adjunctive aripiprazole will improve quality/perceived quality of life.
To identify if adjunct aripiprazole will improve bone turnover as measured by assays of osteoblastic and osteoclastic activity.
To examine side effects associated with adjunctive aripiprazole versus placebo and conduct a cost analysis of adjunctive aripiprazole use.
To evaluate the mediator effects of estrogen, progesterone, prolactin effects on quality of life, bone turnover and sexual functioning.
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.
Minimum age: 18 Years.
Maximum age: 50 Years.
- Subjects will be females of any race, with an age range of 18?50.
- Subjects will meet DSM-IV TR (APA, 2000) criteria for either schizophrenia,
schizoaffective disorder, or bipolar disorder. A best estimate diagnostic approach
will be utilized in which information from the Structured Clinical Interview for
DSM-IV (First et al, 1997) is supplemented by information from family informants,
previous psychiatrists, and medical records to generate a diagnosis
- Women will need to be taking a stable dose of antipsychotic regimen for at least two
months and are considered to have stable symptoms by the treating psychiatrist. This
regimen must include any form of risperidone or paliperidone.
- All women will have a prolactin level > 24 ng/ml (either identified at screening or
from the past 6 weeks in the medical record)
- All women will have evidence of a prolactin related hormonal side effect (amenorrhea,
oligomenorrhea or galactorrhea). This will be determined by patient report/history
and medical record/clinician interview. Oligomenorrhea is defined as infrequent,
irregularly timed episodic bleeding occurring at intervals of more than 35 days from
the previous menstrual cycle and amenorrhea is defined as absence of menstruation for
three menstrual cycles or 6 months (Berek et al. 2002). Galactorrhea is defined as
lactation or copious milk secretion.
- Subjects must be judged competent to participate in the informed consent process and
provide voluntary informed consent, by scoring a 10 out of 12 on the Evaluation to
Sign Consent (ESC)
- Postmenopausal women will be excluded. Since it may be difficult to determine
menopause in patients with amenorrhea, any women more than 45 years will be assessed
for menopausal symptoms such as but not limited to or by: hot flushes, depression,
excitability and fatigue. A medical doctor will advise on the menopausal status.
- Patients with a history of a pituitary tumor (microadenoma, macroadenoma, neoplasm)
will not be included in the study. Previous medical records will be obtained if
possible to examine prolactin levels and medical histories.
- Subjects with documented Cushing's disease, or who are pregnant or currently
lactating post pregnancy will be excluded.
- Subjects who meet DSM-IV TR criteria for alcohol or substance abuse within the last
month are excluded. Subjects with nicotine use or dependence will not be excluded.
- Medications which may increase prolactin or cause sexual dysfunction, including:
metoclopramide, methyldopa, reserpine, amoxapine, droperidol, prochlorperazine,
promethazine, bromocriptine, cabergoline, pergolide, There are many medications that
may affect sexual function (not hormonal side effects) unrelated to dopamine
transmission. These are only permitted as long as the subject has been receiving them
for greater than 4 weeks (SSRIs, mood stabilizers, diuretics, antihypertensives,
H2antagonists, bupropion). We allow these medications to enhance generalizability
Locations and Contacts
Ann Kearns, Phone: 410-402-6854, Email: email@example.com
Maryland Psychiatric Research Center, Catonsville, Maryland 21228, United States; Recruiting
Deanna L. Kelly, Pharm.D., BCPP, Principal Investigator
Starting date: January 2011
Last updated: March 23, 2015