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

• 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: University of Maryland, Baltimore
• Information provided by (Responsible Party): MPRC, University of Maryland, Baltimore

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hyperprolactinemia
• Interventions: Drug: Aripiprazole; Drug: Placebo
• Enrollment: 60

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Aripiprazole	Placebo
Arm/Group Description	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.	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.
Period Title: Overall Study
Started	24	18
Completed	20	15
Not Completed	4	3
Reason Not Completed
Withdrawal by Subject	1	1
Abdominal Pain and scheduled surgery	0	1
Administrative error	0	1
Positive symptom worsening	1	0
Depressive symptoms and nausea	1	0
Non-adherence	1	0

Baseline Characteristics

Arm/Group Title		Aripiprazole	Placebo	Total
Arm/Group Description		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.	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.	Total of all reporting groups
Overall Number of Baseline Participants		24	18	42
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	24 participants	18 participants	42 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	24 100.0%	18 100.0%	42 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	24 participants	18 participants	42 participants
		37.8 (8.9)	36.0 (10.1)	36.6 (9.4)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	24 participants	18 participants	42 participants
	Female	24 100.0%	18 100.0%	42 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	24 participants	18 participants	42 participants
		24	18	42

Outcome Measures

1. Primary Outcome

Title	To Determine if Adjunct Aripiprazole Will Resolve or Improve Prolactin Related Hormonal Side Effects (Amenorrhea, Oligomenorrhea, Galactorrhea).
Description	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

Outcome Measure Data

Analysis Population Description

13 of the 20 Aripiprazole participants had lack of menstruation a the start of the study, and 11 of the 18 participants receiving placebo had lack of menstruation a the start of the study, therefore the analysis of return of menstruation is based on 24 participants.

Arm/Group Title	Aripiprazole	Placebo
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	13	11
Measure Type: Count of Participants; Unit of Measure: Participants
	11 84.6%	7 63.6%

2. Secondary Outcome

Title	To Test Whether Adjunctive Aripiprazole Will Improve Quality/Perceived Quality of Life.
Description	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

Outcome Measure Data

Analysis Population Description

14 of the 20 participants receiving Aripiprazole and 11 of the 18 participants receiving placebo reported sexual dysfunction at baseline.

Arm/Group Title	Aripiprazole	Placebo
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	14	11
Measure Type: Count of Participants; Unit of Measure: Participants
	7 50.0%	1 9.1%

Adverse Events

Time Frame	Weekly for the 16 week study
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Aripiprazole	Placebo
Arm/Group Description	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.	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.
All-Cause Mortality
	Aripiprazole	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/18 (0.00%)
Serious Adverse Events
	Aripiprazole	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/18 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Aripiprazole	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	17/20 (85.00%)	16/18 (88.89%)
Gastrointestinal disorders
Constipation †	6/20 (30.00%)	5/18 (27.78%)
Diarrhea †	9/20 (45.00%)	7/18 (38.89%)
Nausea †	10/20 (50.00%)	4/18 (22.22%)
Vomiting †	10/20 (50.00%)	7/18 (38.89%)
General disorders
Abdominal Pain †	7/20 (35.00%)	6/18 (33.33%)
Bruising Easily †	2/20 (10.00%)	1/18 (5.56%)
Dizziness †	5/20 (25.00%)	4/18 (22.22%)
Dry Mouth †	6/20 (30.00%)	4/18 (22.22%)
Euresis †	5/20 (25.00%)	2/18 (11.11%)
Fever †	1/20 (5.00%)	2/18 (11.11%)
Headache †	6/20 (30.00%)	5/18 (27.78%)
Insomnia †	8/20 (40.00%)	3/18 (16.67%)
Malaise †	7/20 (35.00%)	5/18 (27.78%)
Mucosal ulceration †	4/20 (20.00%)	2/18 (11.11%)
Restlessness †	5/20 (25.00%)	2/18 (11.11%)
Salavation †	4/20 (20.00%)	5/18 (27.78%)
Sedation †	7/20 (35.00%)	6/18 (33.33%)
Sore Throat †	2/20 (10.00%)	4/18 (22.22%)
Tinnitus †	7/20 (35.00%)	2/18 (11.11%)
Tremor †	8/20 (40.00%)	2/18 (11.11%)
Metabolism and nutrition disorders
Anorexia †	4/20 (20.00%)	4/18 (22.22%)
Weight Loss †	4/20 (20.00%)	3/18 (16.67%)
Musculoskeletal and connective tissue disorders
Stiffness †	5/20 (25.00%)	5/18 (27.78%)
Skin and subcutaneous tissue disorders
Rash †	2/20 (10.00%)	3/18 (16.67%)
Urticaria †	1/20 (5.00%)	1/18 (5.56%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: AnnMarie Kearns, MS
• Organization: Maryland Psychiatric Research Center
• Phone: 4104066854
• EMail: akearns@som.umaryland.edu

• Responsible Party: MPRC, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT01338298
• Other Study ID Numbers: HP-00047496, HP-00055154
• First Submitted: April 17, 2011
• First Posted: April 19, 2011
• Results First Submitted: April 17, 2018
• Results First Posted: May 16, 2018
• Last Update Posted: September 27, 2019