SchizophreniaPhase 1NCT03287505
Aripiprazole IM Depot for Chinese Patients With Schizophrenia
A Phase 1 study testing Aripiprazole IM Depot in people with Schizophrenia, run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
This study assess pharmacokinetics and safety of single-administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Aripiprazole IM Depot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2017to 8 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF);
- Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60);
- subjects, both male and female, who are at age between 18 and 64 (also including 18 and 64 years of age) at time of informed consent.
Who cannot join
- Patients who have other psychiatric disorders than schizophrenia based on diagnostic criteria of DSM-IV-TR;
- Score of Positive and Negative Syndrome Scale (PANSS): ≥120;
- Patients with a complication or a history of diabetic mellitus;
- Subjects who are alcoholemia overdependent of drug, or have drug abuse history;
- Other protocol-defined inclusion and exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anding Hospital of Capital Medical University
Beijing, Beijing Municipality, 100088
About this study
Official title: Evaluation of Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation by Single Administration in Chinese Patients With Schizophrenia: a Single-center, Uncontrolled, Open -Label Trial
This study assess pharmacokinetics and safety of single-administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg in patients with schizophrenia.
Read the detailed description
In this study, a single-center, single-dose, single-administration trial will be carried out in patients with schizophrenia diagnosed pursuant to The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), to evaluate pharmacokinetics and safety of single-administration aripiprazole IM Depot (300/400 mg) after its administration in 24 patients with oral tolerance of this drug.
In this study, the washout period before administration is designed as a 35-day duration before administration of the investigational drug (aripiprazoleIM Depot), screening period a 4-week duration (28 days) before administration of the investigational drug, observation period after administration a 20-week duration after administration of the investigational drug and hospital stay a minimum 35-day duration after administration of the investigational drug.
- Conditions
- Schizophrenia
- Being tested
- Aripiprazole IM Depot
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole IM DepotDrug
Also called ABILIFY MAINTENA
administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia.
| Study group | Role | What they receive |
|---|---|---|
| Abilify IM Depot 300mg by once | Experimental | 300 mg dose group: single-administration of Aripiprazole IM Depot (300 mg) in 12 subjects; Receives: Drug: Aripiprazole IM Depot |
| Abilify IM Depot 400mg by once | Experimental | 400 mg dose group: single-administration of Aripiprazole IM Depot (400 mg) in 12 subjects. Receives: Drug: Aripiprazole IM Depot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration
To assess the maximum Plasma Concentration (Cmax) of aripiprazole and its main metabolite OPC-14857
Measured: up to 20 weeks
Time of Maximum Concentration
To assess the time of Maximum Concentration (tmax) of aripiprazole and its main metabolite OPC-14857
Measured: up to 20 weeks
AUC0-∞
To assess the area under the curve for period of medication, from 0 till infinity (AUC0-∞) of aripiprazole and its main metabolite OPC-14857
Measured: up to 20 weeks
Apparent clearance after extravascular administration
To assess the Apparent clearance after extravascular administration (CL/F) of aripiprazole
Measured: up to 20 weeks
Secondary outcomes (3)
Adverse Events
Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment.
Measured: up to 20 weeks
Vital Signs
Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs
Measured: up to 20 weeks
Laboratory Examination
Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin).
Measured: up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start23 Jun 2017
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tao Jiang, Master, Principal investigator, Beijing Anding Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287505
- Sponsor's protocol ID
- 031-403-00050
- Status last verified
- Jan 2020
- First submitted
- 15 May 2017
- Last updated
- 29 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dong F, Wang F, Yuan X, Zhai Y, Uki M, Jiang T, Li A. Single- and multiple-dose pharmacokinetics, safety, and tolerability of Aripiprazole once-monthly, long-acting intramuscular injection for Chinese adults with schizophrenia. BMC Psychiatry. 2025 Oct 1;25(1):912. doi: 10.1186/s12888-025-07407-w.
PubMed 41034820
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation by Single Administration in Chinese Patients With Schizophrenia: a Single-center, Uncontrolled, Open -Label Trial
- ClinicalTrials.gov ID
- NCT03287505
- Acronym / sponsor ID
- 031-403-00050
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assess pharmacokinetics and safety of single-administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg in patients with schizophrenia.
Detailed description
In this study, a single-center, single-dose, single-administration trial will be carried out in patients with schizophrenia diagnosed pursuant to The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), to evaluate pharmacokinetics and safety of single-administration aripiprazole IM Depot (300/400 mg) after its administration in 24 patients with oral tolerance of this drug.
In this study, the washout period before administration is designed as a 35-day duration before administration of the investigational drug (aripiprazoleIM Depot), screening period a 4-week duration (28 days) before administration of the investigational drug, observation period after administration a 20-week duration after administration of the investigational drug and hospital stay a minimum 35-day duration after administration of the investigational drug.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abilify IM Depot 300mg by once | Experimental | Drug: Aripiprazole IM Depot300 mg dose group: single-administration of Aripiprazole IM Depot (300 mg) in 12 subjects; |
| Abilify IM Depot 400mg by once | Experimental | Drug: Aripiprazole IM Depot400 mg dose group: single-administration of Aripiprazole IM Depot (400 mg) in 12 subjects. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF);
- Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60);
- subjects, both male and female, who are at age between 18 and 64 (also including 18 and 64 years of age) at time of informed consent.
Key exclusion criteria (5 listed)
- Patients who have other psychiatric disorders than schizophrenia based on diagnostic criteria of DSM-IV-TR;
- Score of Positive and Negative Syndrome Scale (PANSS): ≥120;
- Patients with a complication or a history of diabetic mellitus;
- Subjects who are alcoholemia overdependent of drug, or have drug abuse history;
- Other protocol-defined inclusion and exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aripiprazole IM DepotAlso: ABILIFY MAINTENAadministration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia. | Drug | Abilify IM Depot 300mg by once, Abilify IM Depot 400mg by once |
Primary outcome
Maximum Plasma Concentration
Time frame: up to 20 weeks
To assess the maximum Plasma Concentration (Cmax) of aripiprazole and its main metabolite OPC-14857
Time of Maximum Concentration
Time frame: up to 20 weeks
To assess the time of Maximum Concentration (tmax) of aripiprazole and its main metabolite OPC-14857
AUC0-∞
Time frame: up to 20 weeks
To assess the area under the curve for period of medication, from 0 till infinity (AUC0-∞) of aripiprazole and its main metabolite OPC-14857
Apparent clearance after extravascular administration
Time frame: up to 20 weeks
To assess the Apparent clearance after extravascular administration (CL/F) of aripiprazole
3 secondary outcomes
Adverse Events
Time frame: up to 20 weeks
Vital Signs
Time frame: up to 20 weeks
Laboratory Examination
Time frame: up to 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Derived from this study: PubMed 41034820Dong F, Wang F, Yuan X, Zhai Y, Uki M, Jiang T, Li A. Single- and multiple-dose pharmacokinetics, safety, and tolerability of Aripiprazole once-monthly, long-acting intramuscular injection for Chinese adults with schizophrenia. BMC Psychiatry. 2025 Oct 1;25(1):912. doi: 10.1186/s12888-025-07407-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Jiang, Master principal investigator
Beijing Anding Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aripiprazole IM Depot in people with Schizophrenia, run by Otsuka Beijing Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (time frame: up to 20 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03287505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.