Trial · NCT01338298

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

NCT01338298, Not applicable, Completed, University of Maryland, Baltimore; results first posted 2018-05-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia. Trials, record NCT01338298. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01338298

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Double-Blind Placebo Controlled Study of Adjunctive Aripiprazole for Symptomatic Hyperprolactinemia In Premenopausal Women With Schizophrenia
NCT number: NCT01338298
Status: Completed
Phases: Not applicable
Enrollment: 60 participants, actual
Lead sponsor: University of Maryland, Baltimore
Conditions: Hyperprolactinemia
Interventions: Aripiprazole, Placebo
First posted: 2011-04-19
Last updated: 2019-09-27
Results first posted: 2018-05-16

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	To Determine if Adjunct Aripiprazole Will Resolve or Improve Prolactin Related Hormonal Side Effects (Amenorrhea, Oligomenorrhea, Galactorrhea).	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).
Secondary	To Test Whether Adjunctive Aripiprazole Will Improve Quality/Perceived Quality of Life.	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).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	To Determine if Adjunct Aripiprazole Will Resolve or Improve Prolactin Related Hormonal Side Effects (Amenorrhea, Oligomenorrhea, Galactorrhea).	16 Weeks	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Test Whether Adjunctive Aripiprazole Will Improve Quality/Perceived Quality of Life.	16 Weeks	14 of the 20 participants receiving Aripiprazole and 11 of the 18 participants receiving placebo reported sexual dysfunction at baseline.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
To Determine if Adjunct Aripiprazole Will Resolve or Improve Prolactin Related Hormonal Side Effects (Amenorrhea, Oligomenorrhea, Galactorrhea).	Aripiprazole	11	Participants
To Determine if Adjunct Aripiprazole Will Resolve or Improve Prolactin Related Hormonal Side Effects (Amenorrhea, Oligomenorrhea, Galactorrhea).	Placebo	7	Participants
To Test Whether Adjunctive Aripiprazole Will Improve Quality/Perceived Quality of Life.	Aripiprazole	7	Participants
To Test Whether Adjunctive Aripiprazole Will Improve Quality/Perceived Quality of Life.	Placebo	1	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Aripiprazole	24
Overall Study	STARTED	Placebo	18
Overall Study	COMPLETED	Aripiprazole	20
Overall Study	COMPLETED	Placebo	15
Overall Study	NOT COMPLETED	Aripiprazole	4
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events50

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal Pain	General disorders	Aripiprazole	7	20
other	Abdominal Pain	General disorders	Placebo	6	18
other	Anorexia	Metabolism and nutrition disorders	Aripiprazole	4	20
other	Anorexia	Metabolism and nutrition disorders	Placebo	4	18
other	Bruising Easily	General disorders	Aripiprazole	2	20
other	Bruising Easily	General disorders	Placebo	1	18
other	Constipation	Gastrointestinal disorders	Aripiprazole	6	20
other	Constipation	Gastrointestinal disorders	Placebo	5	18
other	Diarrhea	Gastrointestinal disorders	Aripiprazole	9	20
other	Diarrhea	Gastrointestinal disorders	Placebo	7	18

1 to 10 of 50Source ClinicalTrials.gov

See all 50 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Aripiprazole	0	20
Total, all-cause mortality	Placebo	0	18
Total, other adverse events	Aripiprazole	17	20
Total, other adverse events	Placebo	16	18
Total, serious adverse events	Aripiprazole	0	20
Total, serious adverse events	Placebo	0	18

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Aripiprazole vs Placebo: To Determine if Adjunct Aripiprazole Will Resolve or Improve Prolactin Related Hormonal Side Effects (Amenorrhea, Oligomenorrhea, Galactorrhea).	Trial comparisons
Aripiprazole vs Placebo: To Test Whether Adjunctive Aripiprazole Will Improve Quality/Perceived Quality of Life.	Trial comparisons
Aripiprazole vs Placebo: deaths from any cause	Trial comparisons
Aripiprazole vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01338298

GET https://conductscience.org/api/trials/v1/NCT01338298/events?page=2

API reference For AI assistants