An interventional study of Aripiprazole and Placebo in Hyperprolactinemia, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-09-27.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Treatment
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.
39 studies on the registry are indexed under Hyperprolactinemia; 4 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 20 interventional studies indexed under Hyperprolactinemia.
Browse Hyperprolactinemia studies →University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Aripiprazole
Drug: Placebo
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.
Also known as: Abilify
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.
To Determine if Adjunct Aripiprazole Will Resolve or Improve Prolactin Related Hormonal Side Effects (Amenorrhea, Oligomenorrhea, Galactorrhea).
We will assess this outcome by monitoring the return of menstruation and the elimination of lactation. We hypothesize that adjunct aripiprazole will resolve hormonal effects in women with symptomatic hyperprolactinemia stabilized on risperidone (or paliperidone).
Time frame: 16 Weeks
To Test Whether Adjunctive Aripiprazole Will Improve Quality/Perceived Quality of Life.
We will measure if patients' symptoms improve, improvement in their sexual dysfunction or distress and if they feel better with the elimination of the side effects. We hypothesize that aripiprazole will improve psychiatric symptoms, quality of life, sexual functioning and perceived wellness relative to placebo in women stabilized on risperidone (or paliperidone).
Time frame: 16 Weeks
| Milestone | Aripiprazole | Placebo |
|---|---|---|
| Started | 24 | 18 |
| Completed | 20 | 15 |
| Not completed | 4 | 3 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Abdominal pain and scheduled surgery | 0 | 1 |
| Withdrew: Administrative error | 0 | 1 |
| Withdrew: Positive symptom worsening | 1 | 0 |
| Withdrew: Depressive symptoms and nausea | 1 | 0 |
| Withdrew: Non-adherence | 1 | 0 |
We will assess this outcome by monitoring the return of menstruation and the elimination of lactation. We hypothesize that adjunct aripiprazole will resolve hormonal effects in women with symptomatic hyperprolactinemia stabilized on risperidone (or paliperidone).
| Participants | Aripiprazole | Placebo |
|---|---|---|
| To Determine if Adjunct Aripiprazole Will Resolve or Improve Prolactin Related Hormonal Side Effects (Amenorrhea, Oligomenorrhea, Galactorrhea). | 11 | 7 |
We will measure if patients' symptoms improve, improvement in their sexual dysfunction or distress and if they feel better with the elimination of the side effects. We hypothesize that aripiprazole will improve psychiatric symptoms, quality of life, sexual functioning and perceived wellness relative to placebo in women stabilized on risperidone (or paliperidone).
| Participants | Aripiprazole | Placebo |
|---|---|---|
| To Test Whether Adjunctive Aripiprazole Will Improve Quality/Perceived Quality of Life. | 7 | 1 |
Collected over Weekly for the 16 week study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aripiprazole | 0/20 (0%) | 0/20 (0%) | 17/20 (85%) |
| Placebo | 0/18 (0%) | 0/18 (0%) | 16/18 (88.9%) |
| Event | Aripiprazole | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 10/20 | 4/18 |
| VomitingGastrointestinal disorders | 10/20 | 7/18 |
| DiarrheaGastrointestinal disorders | 9/20 | 7/18 |
| InsomniaGeneral disorders | 8/20 | 3/18 |
| TremorGeneral disorders | 8/20 | 2/18 |
| Abdominal PainGeneral disorders | 7/20 | 6/18 |
| MalaiseGeneral disorders | 7/20 | 5/18 |
| SedationGeneral disorders | 7/20 | 6/18 |
| TinnitusGeneral disorders | 7/20 | 2/18 |
| ConstipationGastrointestinal disorders | 6/20 | 5/18 |
| Age, Categorical(Participants) | Aripiprazole | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 18 | 42 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Aripiprazole | Placebo | Total |
|---|---|---|---|
| Mean | 37.8 ± 8.9 | 36.0 ± 10.1 | 36.6 ± 9.4 |
| Sex: Female, Male(Participants) | Aripiprazole | Placebo | Total |
|---|---|---|---|
| Female | 24 | 18 | 42 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Aripiprazole | Placebo | Total |
|---|---|---|---|
| United States | 24 | 18 | 42 |
Ran from Jan 2011 to primary completion in Dec 2016, 71 months.
Results were first posted in May 2018, 1 year 5 months after primary completion.
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aripiprazole
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