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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

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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazole Placebo
Hide 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
Arm/Group Title Aripiprazole Placebo Total
Hide 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
Hide 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
1.Primary Outcome
Title To Determine if Adjunct Aripiprazole Will Resolve or Improve Prolactin Related Hormonal Side Effects (Amenorrhea, Oligomenorrhea, Galactorrhea).
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
Time Frame Weekly for the 16 week study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole Placebo
Hide 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%) 
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide 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
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
Layout table for Results Point of Contact information
Name/Title: AnnMarie Kearns, MS
Organization: Maryland Psychiatric Research Center
Phone: 4104066854
EMail: akearns@som.umaryland.edu
Layout table for additonal information
Responsible Party: MPRC, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT01338298     History of Changes
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