Trial · NCT01122927

Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.

NCT01122927, Phase 3, Terminated, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2016-02-08

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features. Trials, record NCT01122927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01122927

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Trial

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

Title: Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.
NCT number: NCT01122927
Status: Terminated
Phases: Phase 3
Enrollment: 524 participants, actual
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Adolescent Schizophrenia, Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Interventions: Aripiprazole
First posted: 2010-05-13
Last updated: 2016-02-08
Results first posted: 2016-02-08
Limitations and caveats: The study was terminated by the Sponsor as the European Medicines Agency P/99/2011Aripiprazole PIP which directed the sponsor to provide 2 years of safety data for at least 100 participants. The objective was met in April 2014.

Source ClinicalTrials.gov

Registered outcomes23

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events (AEs)	Adverse events were recorded from the time of the informed consent was signed throughout the 24 month treatment period until the follow-up visit 30 (± 3) days after the end of trial.	An AE was defined as any untoward medical occurrence in a participant or participant enrolled in a clinical trial and which did not necessarily have a causal relationship with the study medication. A treatment emergent adverse event (TEAE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study medication, whether or not considered to have a causal relationship with the study medication. A serious-AE or reaction was any untoward occurrence that, at any dose, was fatal, life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was any other medically significant event that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Secondary	Incidence of Laboratory Values of Potential Clinical Relevance	Baseline to Month 24	The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. Abnormal laboratory values in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report.
Secondary	Incidence of Physical Examination Findings of Potential Clinical Relevance	Baseline to Month 24	The physical examination evaluation was one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.
Secondary	Incidence of Vital Signs of Potential Clinical Relevance	Baseline to Month 24	Vital signs are taken at Baseline, Weeks 1, 2, 3, 4, 6, 8, and Months 3, 4, 6, 9, 12, 15, 18, 21, 24 of Phase 2 (Visits beyond Month 12 only for de novo subjects). Assessments included orthostatic (supine and standing) blood pressure (BP), heart rate and body temperature. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria. Abnormal vital signs in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report.
Secondary	Mean Change From Baseline by Week in Abnormal Involuntary Movement Scale (AIMS)	Baseline to Month 24	The AIMS Scale was an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10). The first 10 items are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28.
Secondary	Mean Change From Baseline by Week in Simpson-Angus Scale (SAS) Total Score	Baseline to Month 24	The SAS is a rating scale used to measure EPS. The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40.
Secondary	Mean Change From Baseline by Week in Barnes Akathisia Rating Scale (BARS) Score	Baseline to Month 24	The BARS was an EPS rating scale. The BARS was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia).
Secondary	Number of Participants With Cognitive Impairment for Each New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)	Baseline to Month 24	The NY-AACENT is not a validated scale. It was included in this trial because of concerns that regulatory authorities (the European Committee for Medicinal Products for Human Use \[CHMP\] and the Paediatric Sub-Committee of the European Medicinal Agency \[PDCO\]) had regarding drug induced cognitive impairment. No validated scale addressing these issues was available at the time of the trial. The NY-AACENT was used to detect changes in cognitive function subsequent to pharmacological or similar treatments for neurological or psychiatric problems. It was specifically designed to be used in pediatric populations (ages 12 to 17), but could have been utilized with other age groups, as appropriate.
Secondary	Baseline and Post-Baseline Tanner Staging	Baseline to Last Visit	Tanner staging was completed together with the physical examination by the same trial-affiliated clinician in the most inconspicuous manner for the participant as possible. Tanner staging assessment consisted of 2 domains (pubic hair and breast development) for girls and 3 domains (pubic hair, penis development, and testes development) for boys. A participant who reached Stage 5 (both in pubic hair and genitalia) did not need to continue with Tanner Staging assessment and the Tanner Staging scales of this participant were imputed as 5 for all of the following scheduled time points up to and including the completion visit/ET visit. The clinician arrived at a single score summarizing the domains (not individual domain scores) when evaluating the participant. The total shift data for last visit is presented below.
Secondary	Mean Change From Baseline for Columbia-Suicide Severity Rating Scale (C-SSRS) in Suicidal Ideation Intensity Total Score	Baseline to Month 24	Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The suicidal ideation intensity total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) which leads to the range of the total score from 0 to 25. A missing score of any item resulted in a missing total score. If no suicidal ideation was reported, a score of 0 was given to the intensity scale.

1 to 10 of 23Source ClinicalTrials.gov

See all 23 registered outcomes

Outcomes23

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events (AEs)	Adverse events were recorded from the time of the informed consent was signed throughout the 24 month treatment period until the follow-up visit 30 (± 3) days after the end of trial.	All participants who had received at least one dose of oral aripiprazole.	Participants	NUMBER
SECONDARY	Incidence of Laboratory Values of Potential Clinical Relevance	Baseline to Month 24	All participants who had received at least one dose of oral aripiprazole.	participants	NUMBER
SECONDARY	Incidence of Physical Examination Findings of Potential Clinical Relevance	Baseline to Month 24	All participants who had received at least one dose of oral aripiprazole. Any clinically relevant abnormal changes were recorded as TEAEs.	participants	NUMBER
SECONDARY	Incidence of Vital Signs of Potential Clinical Relevance	Baseline to Month 24	All participants who had received at least one dose of oral aripiprazole.	participants	NUMBER
SECONDARY	Mean Change From Baseline by Week in Abnormal Involuntary Movement Scale (AIMS)	Baseline to Month 24	All participants who had received at least one dose of oral aripiprazole.	Units on a scale	MEAN
SECONDARY	Mean Change From Baseline by Week in Simpson-Angus Scale (SAS) Total Score	Baseline to Month 24	All participants who had received at least one dose of oral aripiprazole.	Units on a scale	MEAN
SECONDARY	Mean Change From Baseline by Week in Barnes Akathisia Rating Scale (BARS) Score	Baseline to Month 24	All participants who had received at least one dose of oral aripiprazole.	Units on a scale	MEAN
SECONDARY	Number of Participants With Cognitive Impairment for Each New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)	Baseline to Month 24	All participants who had received at least one dose of oral aripiprazole.	participants	NUMBER
SECONDARY	Baseline and Post-Baseline Tanner Staging	Baseline to Last Visit	All those participants who had received at least one dose of oral aripiprazole during the open-label treatment phase.	participants	NUMBER
SECONDARY	Mean Change From Baseline for Columbia-Suicide Severity Rating Scale (C-SSRS) in Suicidal Ideation Intensity Total Score	Baseline to Month 24	All participants who had received at least one dose of oral aripiprazole.	Units on a scale	MEAN

1 to 10 of 23Source ClinicalTrials.gov

See all 23 outcomes

Results by group162

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

Outcome	Group	Category	Value	Units
Number of Participants With Adverse Events (AEs)	Open-label Treatment Phase	Participants with TEAEs	349	Participants
Number of Participants With Adverse Events (AEs)	Open-label Treatment Phase	Participants with serious TEAEs	49	Participants
Number of Participants With Adverse Events (AEs)	Open-label Treatment Phase	Participants with severe TEAEs	33	Participants
Number of Participants With Adverse Events (AEs)	Open-label Treatment Phase	Discontinued due to AEs	32	Participants
Incidence of Laboratory Values of Potential Clinical Relevance	Open-label Treatment Phase	Chemistry-Alanine transaminase	11	participants
Incidence of Laboratory Values of Potential Clinical Relevance	Open-label Treatment Phase	Chemistry-Aspartate transaminase	8	participants
Incidence of Laboratory Values of Potential Clinical Relevance	Open-label Treatment Phase	Chemistry-Bilirubin, total	20	participants
Incidence of Laboratory Values of Potential Clinical Relevance	Open-label Treatment Phase	Chemistry-Calcium	30	participants
Incidence of Laboratory Values of Potential Clinical Relevance	Open-label Treatment Phase	Chemistry-Chloride	158	participants
Incidence of Laboratory Values of Potential Clinical Relevance	Open-label Treatment Phase	Chemistry-Cholesterol, total, fasting	68	participants

1 to 10 of 162Source ClinicalTrials.gov

See all 162 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Period 1 - Conversion Phase	STARTED	Conversion Phase	297
Period 1 - Conversion Phase	STARTED	Open-label Treatment Phase	0
Period 1 - Conversion Phase	COMPLETED	Conversion Phase	283
Period 1 - Conversion Phase	COMPLETED	Open-label Treatment Phase	0
Period 1 - Conversion Phase	NOT COMPLETED	Conversion Phase	14
Period 1 - Conversion Phase	NOT COMPLETED	Open-label Treatment Phase	0
Period 2- Open-label Treatment Phase	STARTED	Conversion Phase	0
Period 2- Open-label Treatment Phase	STARTED	Open-label Treatment Phase	510
Period 2- Open-label Treatment Phase	COMPLETED	Conversion Phase	0
Period 2- Open-label Treatment Phase	COMPLETED	Open-label Treatment Phase	198

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events64

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	Vomiting	Gastrointestinal disorders	Conversion Phase	4	297
other	Vomiting	Gastrointestinal disorders	Open-label Treatment Phase	30	510
other	Nasopharyngitis	Infections and infestations	Conversion Phase	5	297
other	Nasopharyngitis	Infections and infestations	Open-label Treatment Phase	34	510
other	Weight increased	Investigations	Conversion Phase	1	297
other	Weight increased	Investigations	Open-label Treatment Phase	38	510
other	Headache	Nervous system disorders	Conversion Phase	23	297
other	Headache	Nervous system disorders	Open-label Treatment Phase	67	510
other	Somnolence	Nervous system disorders	Conversion Phase	20	297
other	Somnolence	Nervous system disorders	Open-label Treatment Phase	33	510

1 to 10 of 64Source ClinicalTrials.gov

See all 64 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Conversion Phase
Total, all-cause mortality	Open-label Treatment Phase
Total, other adverse events	Conversion Phase	40	297
Total, other adverse events	Open-label Treatment Phase	194	510
Total, serious adverse events	Conversion Phase	2	297
Total, serious adverse events	Open-label Treatment Phase	49	510

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 comparisons1

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

Comparison
Conversion Phase vs Open-label Treatment Phase: serious adverse events

Source 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.

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