Trial Outcomes & Findings for Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia (NCT NCT01338298)

Last Updated: 2019-09-27

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

16 Weeks

Results posted on

2019-09-27

Participant Flow

Participant milestones

Participant milestones
Measure	Aripiprazole 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 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 Study STARTED	24	18
Overall Study COMPLETED	20	15
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Aripiprazole 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 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 Study Withdrawal by Subject	1	1
Overall Study Abdominal Pain and scheduled surgery	0	1
Overall Study Administrative error	0	1
Overall Study Positive symptom worsening	1	0
Overall Study Depressive symptoms and nausea	1	0
Overall Study Non-adherence	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aripiprazole n=24 Participants 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 n=18 Participants 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 n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37.8 years STANDARD_DEVIATION 8.9 • n=5 Participants	36.0 years STANDARD_DEVIATION 10.1 • n=7 Participants	36.6 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	18 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Aripiprazole n=13 Participants 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 n=11 Participants 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.
To Determine if Adjunct Aripiprazole Will Resolve or Improve Prolactin Related Hormonal Side Effects (Amenorrhea, Oligomenorrhea, Galactorrhea).	11 Participants	7 Participants

SECONDARY outcome

Timeframe: 16 Weeks

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

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).

Outcome measures

Outcome measures
Measure	Aripiprazole n=14 Participants 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 n=11 Participants 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.
To Test Whether Adjunctive Aripiprazole Will Improve Quality/Perceived Quality of Life.	7 Participants	1 Participants

Adverse Events

Aripiprazole

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Aripiprazole n=20 participants at risk 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 n=18 participants at risk 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.
General disorders Abdominal Pain	35.0% 7/20 • Weekly for the 16 week study	33.3% 6/18 • Weekly for the 16 week study
Metabolism and nutrition disorders Anorexia	20.0% 4/20 • Weekly for the 16 week study	22.2% 4/18 • Weekly for the 16 week study
General disorders Bruising Easily	10.0% 2/20 • Weekly for the 16 week study	5.6% 1/18 • Weekly for the 16 week study
Gastrointestinal disorders Constipation	30.0% 6/20 • Weekly for the 16 week study	27.8% 5/18 • Weekly for the 16 week study
Gastrointestinal disorders Diarrhea	45.0% 9/20 • Weekly for the 16 week study	38.9% 7/18 • Weekly for the 16 week study
General disorders Dizziness	25.0% 5/20 • Weekly for the 16 week study	22.2% 4/18 • Weekly for the 16 week study
General disorders Dry Mouth	30.0% 6/20 • Weekly for the 16 week study	22.2% 4/18 • Weekly for the 16 week study
General disorders Euresis	25.0% 5/20 • Weekly for the 16 week study	11.1% 2/18 • Weekly for the 16 week study
General disorders Fever	5.0% 1/20 • Weekly for the 16 week study	11.1% 2/18 • Weekly for the 16 week study
General disorders Headache	30.0% 6/20 • Weekly for the 16 week study	27.8% 5/18 • Weekly for the 16 week study
General disorders Insomnia	40.0% 8/20 • Weekly for the 16 week study	16.7% 3/18 • Weekly for the 16 week study
General disorders Malaise	35.0% 7/20 • Weekly for the 16 week study	27.8% 5/18 • Weekly for the 16 week study
General disorders Mucosal ulceration	20.0% 4/20 • Weekly for the 16 week study	11.1% 2/18 • Weekly for the 16 week study
Gastrointestinal disorders Nausea	50.0% 10/20 • Weekly for the 16 week study	22.2% 4/18 • Weekly for the 16 week study
Skin and subcutaneous tissue disorders Rash	10.0% 2/20 • Weekly for the 16 week study	16.7% 3/18 • Weekly for the 16 week study
General disorders Restlessness	25.0% 5/20 • Weekly for the 16 week study	11.1% 2/18 • Weekly for the 16 week study
General disorders Salavation	20.0% 4/20 • Weekly for the 16 week study	27.8% 5/18 • Weekly for the 16 week study
General disorders Sedation	35.0% 7/20 • Weekly for the 16 week study	33.3% 6/18 • Weekly for the 16 week study
General disorders Sore Throat	10.0% 2/20 • Weekly for the 16 week study	22.2% 4/18 • Weekly for the 16 week study
Musculoskeletal and connective tissue disorders Stiffness	25.0% 5/20 • Weekly for the 16 week study	27.8% 5/18 • Weekly for the 16 week study
General disorders Tinnitus	35.0% 7/20 • Weekly for the 16 week study	11.1% 2/18 • Weekly for the 16 week study
General disorders Tremor	40.0% 8/20 • Weekly for the 16 week study	11.1% 2/18 • Weekly for the 16 week study
Skin and subcutaneous tissue disorders Urticaria	5.0% 1/20 • Weekly for the 16 week study	5.6% 1/18 • Weekly for the 16 week study
Gastrointestinal disorders Vomiting	50.0% 10/20 • Weekly for the 16 week study	38.9% 7/18 • Weekly for the 16 week study
Metabolism and nutrition disorders Weight Loss	20.0% 4/20 • Weekly for the 16 week study	16.7% 3/18 • Weekly for the 16 week study

Additional Information

AnnMarie Kearns, MS

Maryland Psychiatric Research Center

Phone: 4104066854

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place