SchizophreniaPhase 1NCT02220712

A Multicenter Open-label Study Investigating the Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation (OPC-14597 IMD) During Repeated Administration by Injection Into the Deltoid Muscle in Patients With Schizophrenia

A Phase 1 study testing OPC-14597 IMD in people with Schizophrenia, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To assess the pharmacokinetics and safety of aripiprazole intra-muscular (IM) depot formulation in patients with schizophrenia after repeated administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Schizophrenia
What is being tested?: OPC-14597 IMD
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 5 sitesJapan
Study dates: Jul 2014to Apr 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients with a diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual (DSM)-IV-Text Revision (TR) (295.30, 295.10, 295.20, 295.90, 295.60)
Patients who have provided written informed consent by themselves (If the patient is a minor, written consent from a legal representative must be obtained in addition to the patient's own written informed consent.)
Patients, both male and female, aged 18 years or older, but younger than 65 years, at the time of obtaining informed consent
Patients with a body mass index of 18.5 or higher and lower than 35.0
Patients whose mental condition is stable or well maintained for 2 weeks or more without any change to dosage regimen for their non-aripiprazole oral atypical antipsychotic monotherapy prior to obtaining informed consent
Patients who have received aripiprazole in the past

Who cannot join

Patients diagnosed as having a mental disorder other than schizophrenia, as defined by DSM-IV-TR criteria.
Patients with a history or complication of diabetes.
Patients with hepatic, renal, cardiac, or hematopoietic disorders.
Female patients who are pregnant or lactating, who may possibly be pregnant, who wish to become pregnant, or male patients whose partner wishes to become pregnant.
Patients who have a drug allergy or drug hypersensitivity
Patients for whom clozapine has been ineffective, patients who have responded only to clozapine, or patients who are currently being treated with clozapine.

Show all 14Show fewer

Patients with a complication of Parkinson's Disease (excluding drug-induced Parkinsonism).
Patients with a history or a complication of neuroleptic malignant syndrome, rhabdomyolysis, tardive dyskinesia, paralytic ileus or water intoxication.
Patients with a history or a complication of psychological or behavioral abnormalities associated with use of psychoactive substances (abuse of alcohol, narcotics, or organic solvent, etc).
Patients with a history or a complication of suicide attempt or self-injury within 52 weeks prior to obtaining informed consent.
Patients with a history of or a complication of convulsive disorder such as epilepsy.
Patients with a history of or a complication of organic brain disorder including cerebrovascular disease.
Patients with a history or a complication of granulocytopenia or agranulocytosis.
Patients who have received electro-convulsive therapy (ECT) within 12 weeks prior to obtaining informed consent.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Japan5 sites

Study site
Chugoku Region
Study site
Hokkaido Region
Study site
Kanto Region
Study site
Kinki Region
Study site
Kyushu Region

Other trials in Japan

About this study

Conditions: Schizophrenia
Being tested: OPC-14597 IMD
Keywords: Aripiprazole, Deltoid
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OPC-14597 IMDDrug
Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals

Study groups in NCT02220712
Study group	Role	What they receive
Drug: OPC-14597 IMD	Experimental	Not described Receives: Drug: OPC-14597 IMD

What is being measured

The primary outcome is the main question the study is designed to answer.

OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections
Measured: 672 hours postdose of the first, second, third, fourth, and fifth IMD injections

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Apr 2015

First posted20 Aug 2014 (estimated)
Study startJul 2014
Primary completionApr 2015
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02220712
Sponsor's protocol ID: 031-13-005
Other IDs: JapicCTI-142635
Status last verified: Jan 2021
First submitted: 18 Aug 2014
Last updated: 25 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Open-label Study Investigating the Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation (OPC-14597 IMD) During Repeated Administration by Injection Into the Deltoid Muscle in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT02220712
Acronym / sponsor ID: 031-13-005
Conditions: Schizophrenia
Keywords: Aripiprazole, Deltoid
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 20 Aug 2014 (estimated)
Results: Posted 25 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Drug: OPC-14597 IMD	Experimental	Drug: OPC-14597 IMD

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Patients with a diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual (DSM)-IV-Text Revision (TR) (295.30, 295.10, 295.20, 295.90, 295.60)
Patients who have provided written informed consent by themselves (If the patient is a minor, written consent from a legal representative must be obtained in addition to the patient's own written informed consent.)
Patients, both male and female, aged 18 years or older, but younger than 65 years, at the time of obtaining informed consent
Patients with a body mass index of 18.5 or higher and lower than 35.0
Patients whose mental condition is stable or well maintained for 2 weeks or more without any change to dosage regimen for their non-aripiprazole oral atypical antipsychotic monotherapy prior to obtaining informed consent

Key exclusion criteria (14 listed)

Patients diagnosed as having a mental disorder other than schizophrenia, as defined by DSM-IV-TR criteria.
Patients with a history or complication of diabetes.
Patients with hepatic, renal, cardiac, or hematopoietic disorders.
Female patients who are pregnant or lactating, who may possibly be pregnant, who wish to become pregnant, or male patients whose partner wishes to become pregnant.
Patients who have a drug allergy or drug hypersensitivity

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
OPC-14597 IMDAdministration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals	Drug	Drug: OPC-14597 IMD

Primary outcome

OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections
Time frame: 672 hours postdose of the first, second, third, fourth, and fifth IMD injections

Results and safety

Results posted to the registry on 25 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OPC-14597 IMD	17	13

Primary outcome: OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections

Time frame: 672 hours postdose of the first, second, third, fourth, and fifth IMD injections. Mean (Standard Deviation). Unit: ng/mL

Measure	OPC-14597 IMD (First Dose) n = 13	OPC-14597 IMD (Second Dose) n = 13	OPC-14597 IMD (Third Dose) n = 13	OPC-14597 IMD (Fourth Dose) n = 13	OPC-14597 IMD (Fifth n = 13
Value	91.9 (29.4)	141 (54.0)	171 (76.1)	198 (102)	201 (88.9)

Population analysed: Pharmacokinetic analysis set included subjects whose plasma concentrations were measured without deviation at all blood sampling timepoints during the OPC-14597 IMD treatment period.

Adverse events

Time frame: 20 weeks of treatment period + posttreatment observation period (57 days after administration of the fifth IMD). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OPC-14597 IMD	2 of 17 (11.8%)	15 of 17 (88.2%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Schizophrenia

Recruiting
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RecruitingObservational study
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Late Onset Schizophrenia, Delusional Disorder (Late Onset)
Active, not recruitingObservational study
Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections
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Recruiting
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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.

Jun-ichi Hashimoto, PhD study director

Otsuka Pharmaceutical Co., Ltd.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OPC-14597 IMD in people with Schizophrenia, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites in Japan.

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 6 inclusion and 14 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 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 25 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections (time frame: 672 hours postdose of the first, second, third, fourth, and fifth IMD injections). 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 NCT02220712.

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 25 Jan 2021.