Trial record 14 of 414 for:
ARIPIPRAZOLE
Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia (DAAMSEL)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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 Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
---|---|---|
![]() |
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 | |
---|---|---|---|---|
![]() |
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 | |
![]() |
[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
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 |