A Phase 1 interventional study of Aripiprazole in Schizophrenia and Mania, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. (part of Otsuka Holdings Co., Ltd.) · Phase 1, Interventional, and Treatment
Among 126 studies testing aripiprazole in Schizophrenia — 4 open to participants now, 4 under way, 1 of them phase 3. Aripiprazole · Schizophrenia.
Among the 126 studies testing aripiprazole in Schizophrenia, this one is the 109th largest by enrollment of the 125 interventional ones, is one of 15 that started in 2004, is one of 13 in phase 1, and was the 9th registered.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's enrollment of 21 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →4 of the 126 studies testing aripiprazole in Schizophrenia are open now, in 2 countries. Each count lists the studies.
Aripiprazole: first FDA approval 2002 (ABILIFY), first EMA approval 2004. What it is approved for, and how studies give it, is on its page →
Of the 331 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 257 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.
This study: 10 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →126 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 15 started in 2004.
Median enrollment 130 across the 125 interventional studies. Of the 105 that completed or were terminated, 47 (45%) have results posted.
66 of 126 have an industry lead sponsor. The 10 most frequent:
Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 295 studies on the registry; 18 are open to participants now.
Of its 106 completed or terminated interventional studies of FDA-regulated products, 71 (67%) have results posted.
90 studies in Schizophrenia by Otsuka Pharmaceutical Development & Commercialization, Inc.: 1 open now, 2 under way, 1 of them phase 3. Of 87 finished, 55 (63%) have results posted.
Among the 90 studies in Schizophrenia by Otsuka Pharmaceutical Development & Commercialization, Inc., this one is the 78th largest by enrollment of the 88 interventional ones, is one of 6 that started in 2004, is one of 28 in phase 1, and was the 7th registered.
Otsuka Pharmaceutical Development & Commercialization, Inc.’s Schizophrenia studies by the year they started, since 1998.
1 of the studies testing aripiprazole in Schizophrenia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07547384CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Steady-state Bioequivalence Study of Aripiprazole for Injection in Patients With Schizophrenia. | 2027-09-05 |
Among the 126 studies testing aripiprazole in Schizophrenia, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Otsuka Pharmaceutical Development & Commercialization, Inc.’s 90 in Schizophrenia:
The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 20 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 20 mg for 14 days.
Drug: Aripiprazole
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 25 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 25 mg for 14 days.
Drug: Aripiprazole
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 30 mg. Following the dose-escalation phase, participants entered the fixed-dose phase and received 30 mg for 14 days.
Drug: Aripiprazole
Aripiprazole tablets ranging from 2 to 30 mg to be taken orally once a day.
Also known as: Abilify®
Percentage of Participants Able to Tolerate Maximum Dose Level
Dose toleration was defined as the following: during the course of the study the participant does not experience any untoward events or potentially clinically significant changes from baseline in laboratory values, vital signs, electrocardiogram (ECG) tracings, or Extrapyramidal symptoms (EPS) ratings (evaluation of parkinsonism, dyskinesia, and akathisia) that are assessed as possibly related to the drug, and would warrant adjustment or discontinuation of the study drug.
Time frame: 14 Days
Number of Participants With Adverse Events, Serious Adverse Events and Discontinuation Due to Adverse Event as a Measure of Safety
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Time frame: 57 days
Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
Blood samples were collected pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 14 and were analyzed by a validated High-Performance Liquid Chromatography/ Mass Spectrometry (HPLC-MS/MS) method for aripiprazole. Css,max value was determined using observed data.
Time frame: Pre-dose and 1 to 24 hours post-dose on Day 14
Aripiprazole Time to Maximum (Peak) Plasma Concentration (Tmax)
Blood samples were collected pre-dose and 1, 2, 3, 4, 6, 8, 10, 24 and 25 hours post dose on Day 14 and were analyzed by a validated High-Performance Liquid Chromatography/ Mass Spectrometry (HPLC-MS/MS) method for aripiprazole. Tmax value was determined using observed data.
Time frame: Pre-dose and 1 to 25 hours post-dose on Day 14
Aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ)
Blood samples were collected pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post-dose on Day 14 and were analyzed by a validated High-Performance Liquid Chromatography/ Mass Spectrometry (HPLC-MS/MS) method for aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule to the actual time of the 24-hour sample.
Time frame: Pre-dose and 1 to 24 hours post-dose on Day 14
Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) at Day 1 and Day 14
The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" using an 8-point scale where 0=not assessed, 1=normal, not at all ill; to 7=among the most extremely ill patients. A negative change from Baseline indicated improvement.
Time frame: Baseline, Day 1, Day 14
Clinical Global Impression Scale-Improvement (CGI-I) Score at Day 1 and Day 14
The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: "Compared to his/her condition at baseline (prior to randomization), how much has the patient changed?" using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement.
Time frame: Days 1 and 14
| Milestone | Aripiprazole 20 mg | Aripiprazole 25 mg | Aripiprazole 30 mg |
|---|---|---|---|
| Started | 8 | 7 | 6 |
| Completed | 8 | 7 | 6 |
| Not completed | 0 | 0 | 0 |
| Milestone | Aripiprazole 20 mg | Aripiprazole 25 mg | Aripiprazole 30 mg |
|---|---|---|---|
| Started | 8 | 7 | 6 |
| Completed | 7 | 6 | 6 |
| Not completed | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 |
| Milestone | Aripiprazole 20 mg | Aripiprazole 25 mg | Aripiprazole 30 mg |
|---|---|---|---|
| Started | 7 | 6 | 6 |
| Completed | 6 | 5 | 6 |
| Not completed | 1 | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 |
Dose toleration was defined as the following: during the course of the study the participant does not experience any untoward events or potentially clinically significant changes from baseline in laboratory values, vital signs, electrocardiogram (ECG) tracings, or Extrapyramidal symptoms (EPS) ratings (evaluation of parkinsonism, dyskinesia, and akathisia) that are assessed as possibly related to the drug, and would warrant adjustment or discontinuation of the study drug.
| Percentage of Participants | Aripiprazole 20 mg | Aripiprazole 25 mg | Aripiprazole 30 mg |
|---|---|---|---|
| Percentage of Participants Able to Tolerate Maximum Dose Level | 83 | 80 | 100 |
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
| participants | Aripiprazole 20 mg | Aripiprazole 25 mg | Aripiprazole 30 mg |
|---|---|---|---|
| Adverse Event | 8 | 7 | 6 |
| Serious Adverse Event | 0 | 0 | 0 |
| Discontinued due to Adverse Event | 0 | 1 | 0 |
Blood samples were collected pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 14 and were analyzed by a validated High-Performance Liquid Chromatography/ Mass Spectrometry (HPLC-MS/MS) method for aripiprazole. Css,max value was determined using observed data.
| ng/mL | Aripiprazole 20 mg | Aripiprazole 25 mg | Aripiprazole 30 mg |
|---|---|---|---|
| Aripiprazole Maximum Steady State Plasma Concentration (Css,Max) | 435 ± 137 | 529 ± 341 | 653 ± 213 |
Blood samples were collected pre-dose and 1, 2, 3, 4, 6, 8, 10, 24 and 25 hours post dose on Day 14 and were analyzed by a validated High-Performance Liquid Chromatography/ Mass Spectrometry (HPLC-MS/MS) method for aripiprazole. Tmax value was determined using observed data.
| hours | Aripiprazole 20 mg | Aripiprazole 25 mg | Aripiprazole 30 mg |
|---|---|---|---|
| Aripiprazole Time to Maximum (Peak) Plasma Concentration (Tmax) | 2.00 (1.00 to 24.08) | 2.05 (1.00 to 4.02) | 2.00 (1.00 to 8.00) |
Blood samples were collected pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post-dose on Day 14 and were analyzed by a validated High-Performance Liquid Chromatography/ Mass Spectrometry (HPLC-MS/MS) method for aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule to the actual time of the 24-hour sample.
| ng⋅h/mL | Aripiprazole 20 mg | Aripiprazole 25 mg | Aripiprazole 30 mg |
|---|---|---|---|
| Aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ) | 8031 ± 3745 | 9488 ± 7001 | 12770 ± 5444 |
The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" using an 8-point scale where 0=not assessed, 1=normal, not at all ill; to 7=among the most extremely ill patients. A negative change from Baseline indicated improvement.
| units on a scale | Aripiprazole 20 mg | Aripiprazole 25 mg | Aripiprazole 30 mg |
|---|---|---|---|
| Day 1 | -0.86 ± 0.90 | -1.50 ± 0.55 | -2.00 ± 0.63 |
| Day 14 | -1.57 ± 0.98 | -1.43 ± 1.13 | -2.33 ± 0.52 |
The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: "Compared to his/her condition at baseline (prior to randomization), how much has the patient changed?" using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement.
| units on a scale | Aripiprazole 20 mg | Aripiprazole 25 mg | Aripiprazole 30 mg |
|---|---|---|---|
| Day 1 | 2.29 ± 0.76 | 1.83 ± 0.41 | 1.33 ± 0.52 |
| Day 14 | 1.67 ± 0.52 | 1.40 ± 0.55 | 1.33 ± 0.82 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aripiprazole 20 mg | — | 0/8 (0%) | 8/8 (100%) |
| Aripiprazole 25 mg | — | 0/7 (0%) | 7/7 (100%) |
| Aripiprazole 30 mg | — | 0/6 (0%) | 6/6 (100%) |
| Event | Aripiprazole 20 mg | Aripiprazole 25 mg | Aripiprazole 30 mg |
|---|---|---|---|
| HeadacheNervous system disorders | 4/8 | 2/7 | 3/6 |
| Abdominal pain upperGastrointestinal disorders | 1/8 | 3/7 | 1/6 |
| SedationNervous system disorders | 0/8 | 0/7 | 2/6 |
| VomitingGastrointestinal disorders | 1/8 | 2/7 | 1/6 |
| FatigueGeneral disorders | 0/8 | 2/7 | 0/6 |
| PyrexiaGeneral disorders | 0/8 | 2/7 | 0/6 |
| DizzinessNervous system disorders | 1/8 | 2/7 | 1/6 |
| AcneSkin and subcutaneous tissue disorders | 0/8 | 2/7 | 0/6 |
| Vision blurredEye disorders | 2/8 | 0/7 | 0/6 |
| Musculoskeletal stiffnessMusculoskeletal and connective tissue disorders | 2/8 | 1/7 | 0/6 |
| Age, Continuous(years) | Aripiprazole 20 mg | Aripiprazole 25 mg | Aripiprazole 30 mg | Total |
|---|---|---|---|---|
| Mean | 12.4 ± 2.5 | 13.3 ± 1.8 | 10.8 ± 1.2 | 12.2 ± 2.1 |
| Sex: Female, Male(Participants) | Aripiprazole 20 mg | Aripiprazole 25 mg | Aripiprazole 30 mg | Total |
|---|---|---|---|---|
| Female | 4 | 3 | 0 | 7 |
| Male | 4 | 4 | 6 | 14 |
No study locations are listed for this record.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aripiprazole
Otsuka Pharmaceutical Development & Commercialization, Inc. →