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Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia (DAAMSEL)

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ClinicalTrials.gov Identifier: NCT01338298
Recruitment Status : Completed
First Posted : April 19, 2011
Results First Posted : May 16, 2018
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
MPRC, University of Maryland, Baltimore

Tracking Information
First Submitted Date  ICMJE April 17, 2011
First Posted Date  ICMJE April 19, 2011
Results First Submitted Date  ICMJE April 17, 2018
Results First Posted Date  ICMJE May 16, 2018
Last Update Posted Date September 27, 2019
Actual Study Start Date  ICMJE January 2011
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2011)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01338298 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2011)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia
Official Title  ICMJE Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia
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.

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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hyperprolactinemia
Intervention  ICMJE
  • Drug: 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
  • Drug: 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.
Study Arms  ICMJE
  • Active Comparator: Aripiprazole
    Intervention: Drug: Aripiprazole
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2017)
60
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2011)
80
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01338298
Other Study ID Numbers  ICMJE HP-00047496, HP-00055154
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MPRC, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deanna L Kelly, Pharm.D., BCPP University of Maryland, College Park
PRS Account University of Maryland, Baltimore
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP