Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 5/18/2018 |
| Start Date: | January 2011 |
| End Date: | December 2016 |
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.
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.
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.
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
We found this trial at
1
site
Catonsville, Maryland 21228
Principal Investigator: Deanna L. Kelly, Pharm.D., BCPP
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