Ignite Creation Date:
2024-05-05 @ 11:28 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01338298
Status:
COMPLETED
Last Update Posted:
2019-09-27
First Post:
2011-04-17
Brief Title:
Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAAMSEL
Brief 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
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 mgday once daily and increased to 10mg by mouth once daily at the end of week 2 and then increased to 15 mgday 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 eg benztropine and diphenhydramine for extrapyramidal side effects propranolol for akathisia and benzodiazepines eglorazepam 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None