Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia (DAAMSEL)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia|
- To determine if adjunct aripiprazole will resolve or improve prolactin related hormonal side effects (amenorrhea, oligomenorrhea, galactorrhea). [ Time Frame: 16 Weeks ]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).
- To test whether adjunctive aripiprazole will improve quality/perceived quality of life. [ Time Frame: 16 Weeks ]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).
- To identify if adjunct aripiprazole will improve bone turnover as measured by assays of osteoblastic and osteoclastic activity. [ Time Frame: 16 Weeks ]We will measure blood and urine tests to determine if the adjunct treatment will preserve and prevent bone loss. We hypothesize that osteoclastic activity will be greater and osteoclastic activity will be less in women treated with adjunct aripiprazole relative to placebo in women stabilized on risperidone (or paliperidone).
- To examine side effects associated with adjunctive aripiprazole versus placebo and conduct a cost analysis of adjunctive aripiprazole use. [ Time Frame: 16 Weeks ]We will measure if the benefits from the adjunctive treatment outweigh the costs of the combined treatment. We hypothesize that side effects with adjunct aripiprazole (extrapyramidal side effects, weight gain and others) will not differ from placebo. We will estimate the additional costs and assess the relationship of adjunctive aripiprazole use with the perceived tolerability of continued use of risperidone (or paliperidone).
- To evaluate the mediator effects of estrogen, progesterone, prolactin effects on quality of life, bone turnover and sexual functioning. [ Time Frame: 16 Weeks ]We will measure hormonal levels in blood and saliva to see the effects of treatment and improvements in symptoms. In exploratory analyses, we will examine the relationship of sex hormone changes to various outcomes. Sex hormone levels may predict improvement and serve as a biomarker for predicting outcome or bone turnover and determining optimal aripiprazole dose for individual patients. For example, women who have return of menses but do not ovulate, as evidenced by lack of luteal progesterone surge, may have less improvement in bone turnover and sexual side effects.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
|Active Comparator: Aripiprazole||
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.
Other Name: Abilify
|Placebo Comparator: Placebo||
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338298
|Contact: Ann Kearnsfirstname.lastname@example.org|
|Contact: Stephanie Feldmanemail@example.com|
|United States, Maryland|
|Maryland Psychiatric Research Center||Recruiting|
|Catonsville, Maryland, United States, 21228|
|Principal Investigator: Deanna L. Kelly, Pharm.D., BCPP|
|Principal Investigator:||Deanna L Kelly, Pharm.D., BCPP||University of Maryland|