SchizophreniaPhase 4NCT03839251
Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients
A Phase 4 study testing abilify maintena in people with Schizophrenia, run by Chonbuk National University Hospital at 5 sites in South Korea.
Trial summary
The aim of the study is to investigate the effectiveness of Aripiprazole long-acting injection in recent onset and chronic schizophrenia patients Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- abilify maintena
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 1 Jun 2018to 30 Sep 2020
- Phase
- Phase 4
- 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with schizophrenia according to DSM-5 diagnostic standards
- men and women aged 19 and under 60
- a person who is being given an atypical antipsychotic.
- Patients should be able to reasonably cooperate with the questionnaire to be used for the study
- a person who fully understands the purpose of the study and signs the consent
- stable outpatient before screening without changing the volume of antipsychotics for at least two weeks
Who cannot join
- a person who has a serious and unstable physical condition either now or in the past
- A fertile woman who is currently pregnant or breastfeeding, or who is either unwilling or unable to use acceptable contraception until the clinical trial is complete.
- a person suffering from severe drug allergies or complex and severe drug reactions
- Patients who have taken clozapine in the last 60 days
- subjects showing significant risk of suicide or significant risk of violent behavior based on past history or investigator's judgment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Department of Psychiatry, Inje University Haeundae Paik Hospital
Busan
Department of Psychiatry, Kyungpook National University Hospital
Daegu
Department of Psychiatry, Yeungnam University Medical Center
Daegu
Department of Psychiatry, Chonnam National University Medical School
Gwangju
Department of Psychiatry, Chonbuk National University Hospital
Jeonju
About this study
The aim of the study is to investigate the effectiveness of Aripiprazole long-acting injection in recent onset and chronic schizophrenia patients
Read the detailed description
The aim of this study is to investigate the effectiveness of Aripiprazole long-acting injection in recent onset and chronic schizophrenia patients
- Conditions
- Schizophrenia
- Being tested
- abilify maintena
- Keywords
- aripiprazole, long-acting injection
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abilify maintenaDrug
Also called aripiprazole
aripiprazole 400mg or 300mg, IM, Once a month
| Study group | Role | What they receive |
|---|---|---|
| abilify maintena | Other | aripiprazole 400mg or 300mg, IM, Once a month Receives: Drug: abilify maintena |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline PSP(Personal and Social Performance scale) at 12weeks
PSP(Personal and Social Performance scale) was measured in baseline and 12week. Minimum of PSP(Personal and Social Performance Scale) is 1, maximum is 100. The lower number is worse outcome.
Measured: 12weeks
Change from Baseline PSP(Personal and Social Performance scale) at 24weeks
PSP(Personal and Social Performance scale) was measured in baseline and 24week. Minimum of PSP(Personal and Social Performance Scale) is 1, maximum is 100. The lower number is worse outcome.
Measured: 24weeks
Secondary outcomes (8)
Efficacy Assessment by CGI-S(Clinical global impression-schizophrenia)
Clinical global impression-schizophrenia(CGI-S)
There are Positive Symptoms, Negative Symptoms, Depressive Symptoms, Cognitive Symptoms and Overall severity in the Clinical global impression-schizophrenia(CGI-S). minimum of each items(Positive Symptoms, Negative Symptoms, Depressive Symptoms, Cognitive Symptoms and Overall severity) is 1, Maximum is 7. The higher number is worse outcome.
Measured: baseline, 4weeks, 8weeks, 12weeks, 16weeks, 20weeks, 24weeks
Efficacy Assessment by ERT(Emotional Recognition Test)
Emotional Recognition Test(ERT)
minimum of ERT(Emotional Recognition Test) total score is 0, Maximum is 54. The lower number is worse outcome.
Measured: baseline, 24weeks
Efficacy Assessment by PANSS(Positive and Negative Syndrome Scale)
Positive and Negative Syndrome Scale(PANSS)
There are Positive Scale, Negative Scale and General Psychopathology Scale in the PANSS(Positive and Negative Syndrome Scale). minimum of each items(Positive Scale, Negative Scale and General Psychopathology Scale) is 1, Maximum is 7. The higher number is worse outcome.
Measured: baseline, 12weeks, 24weeks
Efficacy Assessment by self rating scale
Subjective Wellbeing under Neuroleptics(SWN-K)
SWN-K(Subjective Wellbeing under Neuroleptics) consists of 20 questions. The minimum score for each question is zero and the maximum score is five. The reverse scoring questions include 1,4,6,9,10,11,12,14,16,17. The total score of the whole item is obtained, and the lower the score, the worse the subjective well-being.
Measured: baseline, 12weeks, 24weeks
Safety Assessment by Simpson-Angus Scale(SAS)
Simpson-Angus Scale(SAS)
minimum of each items(Gait, Arm Dropping, Shoulder Shaking, Elbow Rigidity, Fixation of Position or Wrist Rigidity, Leg Pendulousness, Head Dropping, Glabella Tap, Tremor, Salivation) in the SAS(Simpson-Angus Scale) is 0, Maximum is 4. minimum of total scores in the SAS(Simpson-Angus Scale) is 0, Maximum is 40. The higher number is worse outcome.
Measured: baseline, 12weeks, 24weeks
Safety Assessment by Barnes Akathisia Rating Scale(BARS)
Barnes Akathisia Rating Scale(BARS)
minimum of each items(Objective, Subjective, Distress related to restlessness) in the BAS(Barnes Akathisia Rating Scale) is 0, Maximum is 3. Minimum of Global clinical assessment of akathisia in the BARS is 0, Maximum is 5. The higher number is worse outcome.
Measured: baseline, 12weeks, 24weeks
Safety Assessment by Abnormal Involuntary Movement Scale(AIMS)
Abnormal Involuntary Movement Scale(AIMS)
minimum of each items in the AIMS(Abnormal Involuntary Movement Scale) is 0, Maximum is 4. The higher number is worse outcome.
Measured: baseline, 12weeks, 24weeks
Safety Assessment by self report scale
Visual Analogue Scale(VAS)
minimum of VAS(Visual Analogue Scale) is 0, Maximum is 10. The higher number is worse outcome.
Measured: baseline, 12weeks, 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Jun 2018
- Primary completion22 Jan 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Young Chul Chung, Chonbuk National University Hospital
- Investigators
- Young-chul Chung, MD, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839251
- Sponsor's protocol ID
- CUH 2018-02-011-005
- Status last verified
- Jan 2021
- First submitted
- 29 Jan 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT03839251
- Acronym / sponsor ID
- CUH 2018-02-011-005
- Conditions
- Schizophrenia
- Keywords
- aripiprazole, long-acting injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 15 Feb 2019 (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.
The aim of the study is to investigate the effectiveness of Aripiprazole long-acting injection in recent onset and chronic schizophrenia patients
Detailed description
The aim of this study is to investigate the effectiveness of Aripiprazole long-acting injection in recent onset and chronic schizophrenia patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| abilify maintena | Other | Drug: abilify maintenaaripiprazole 400mg or 300mg, IM, Once a month |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients diagnosed with schizophrenia according to DSM-5 diagnostic standards
- men and women aged 19 and under 60
- a person who is being given an atypical antipsychotic.
- Patients should be able to reasonably cooperate with the questionnaire to be used for the study
- a person who fully understands the purpose of the study and signs the consent
Key exclusion criteria (5 listed)
- a person who has a serious and unstable physical condition either now or in the past
- A fertile woman who is currently pregnant or breastfeeding, or who is either unwilling or unable to use acceptable contraception until the clinical trial is complete.
- a person suffering from severe drug allergies or complex and severe drug reactions
- Patients who have taken clozapine in the last 60 days
- subjects showing significant risk of suicide or significant risk of violent behavior based on past history or investigator's judgment
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 |
|---|---|---|
| abilify maintenaAlso: aripiprazolearipiprazole 400mg or 300mg, IM, Once a month | Drug | abilify maintena |
Primary outcome
Change from Baseline PSP(Personal and Social Performance scale) at 12weeks
Time frame: 12weeks
PSP(Personal and Social Performance scale) was measured in baseline and 12week. Minimum of PSP(Personal and Social Performance Scale) is 1, maximum is 100. The lower number is worse outcome.
Change from Baseline PSP(Personal and Social Performance scale) at 24weeks
Time frame: 24weeks
PSP(Personal and Social Performance scale) was measured in baseline and 24week. Minimum of PSP(Personal and Social Performance Scale) is 1, maximum is 100. The lower number is worse outcome.
8 secondary outcomes
Efficacy Assessment by CGI-S(Clinical global impression-schizophrenia)
Time frame: baseline, 4weeks, 8weeks, 12weeks, 16weeks, 20weeks, 24weeks
Efficacy Assessment by ERT(Emotional Recognition Test)
Time frame: baseline, 24weeks
Efficacy Assessment by PANSS(Positive and Negative Syndrome Scale)
Time frame: baseline, 12weeks, 24weeks
Efficacy Assessment by self rating scale
Time frame: baseline, 12weeks, 24weeks
Safety Assessment by Simpson-Angus Scale(SAS)
Time frame: baseline, 12weeks, 24weeks
Safety Assessment by Barnes Akathisia Rating Scale(BARS)
Time frame: baseline, 12weeks, 24weeks
Safety Assessment by Abnormal Involuntary Movement Scale(AIMS)
Time frame: baseline, 12weeks, 24weeks
Safety Assessment by self report scale
Time frame: baseline, 12weeks, 24weeks
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 27 Jan 2021.
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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.
Young-chul Chung, MD principal investigator
Chonbuk National University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing abilify maintena in people with Schizophrenia, run by Chonbuk National University Hospital at 5 sites in South Korea.
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 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 27 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change from Baseline PSP(Personal and Social Performance scale) at 12weeks (time frame: 12weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2021.