Acute Schizophrenia EpisodePhase 4NCT03289026
Pharmacologic Treatment of Acute Episode of Schizophrenia: a Real World Study
A Phase 4 study testing Aripiprazole in people with Acute Schizophrenia Episode, run by Peking University at 12 sites in China.
Trial summary
This study attempts to observe the effectiveness and safety of aripiprazole in hospitalized patients with acute schizophrenia episode, and to compare the different drug regimens that may be involved in order to clarify the characteristics of the population for taking aripiprazole and provide reference for clinical… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Schizophrenia Episode
- What is being tested?
- Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 770 participants
- Where
- 12 sitesChina
- Study dates
- 1 Sep 2017to 2 Feb 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meeting International Classification of Diseases (tenth version, ICD-10) criteria for schizophrenia.
- acute episode; inpatients
- Age from 18-65 years old (inclusion), male or female
- PANSS total score at least 70
- scoring ≥ 4 on at least two of the following PANSS items: P1 (delusions), P2 (conceptual disorganisation), P3 (hallucinations), P6 (suspiciousness/persecution) ; and PANSS positive score is higher than PANSS negative score
- Written informed consent
Who cannot join
- other serious diseases;
- Pregnant or breast feeding women or planning a pregnancy
- Patients in a state of drug-induced malignant syndrome or serious extrapyramidal side effect, or with a history of malignant syndrome or serious extrapyramidal side effect;
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Allergy to Aripiprazole
- History of alcohol or drug abuse or dependence in the past 1-year before screening
Show all 13Show fewer
- mental retardation; bipolar disorder; major depressive disorder;
- Currently using one kind of antipsychotic drug at a dose that exceeds the recommended maximum dose for two weeks, but no improvement in core symptoms; or currently using two kinds of antipsychotic drugs, at least one of which reaches or exceeds the recommended maximum dose for two weeks, but no improvement in core symptoms; or currently using three kinds of antipsychotic drugs or more;
- Refractory schizophrenia patients who did not respond to treatments of two different type antipsychotics with adequate dose and course
- Patients with clinically significant abnormalities on electrocardiogram or laboratory tests
- Patients with clinically significant abnormalities on liver function (ALT or AST>2 times of higher limit of normal range)
- Patients who had Electroconvulsive Therapy (ECT) in the past 2 months
- Participation in a clinical trial of another drug within 4 weeks prior to study entry
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing Anding Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069
Beijing HuiLongGuan Hospital
Beijing, Beijing Municipality, 100096
Peking University Sixth Hospital
Beijing, Beijing Municipality, 100191
102 Miltary Hospital of China
Changzhou, Jiangsu, 213003
The Fourth People's Hospital of Chengdu
Chengdu, Sichuan, 610036
Hangzhou Seventh People's Hospital
Hanzhou, Zhejiang, 310013
The First Haerbin Psychiatric Hospital
Harbin, Heilongjiang, 150056
The Fourth People's Hospital of Hefei
Hefei, Anhui, 230000
Shandong Mental Health Center
Jinan, Shandong, 250014
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200003
Wuhan Mental Health Center
Wuhan, Hubei, 430000
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: A Multicenter, Open-label Study to Evaluate the Effectiveness and Safety of Aripiprazole in Patients With Acute Episode of Schizophrenia
This study attempts to observe the effectiveness and safety of aripiprazole in hospitalized patients with acute schizophrenia episode, and to compare the different drug regimens that may be involved in order to clarify the characteristics of the population for taking aripiprazole and provide reference for clinical rational drug use.
Read the detailed description
The control of acute schizophrenia effectively and rapidly will build up the confidence of patients on treatments. These early effects may influence the long-term compliance and prognosis of patients. Aripiprazole is an important drug in first line treatment of schizophrenia. However, at present in China, the application of aripiprazole in some patients with acute schizophrenia is not appropriate, leading to poor control of the positive symptoms of the acute phase.
The purpose of this single-arm, open-label trial is to study the situation of the use of aripiprazole in hospitalized patients with acute schizophrenia episode, and to compare the different drug regimens that may be involved in order to supply important information for optimizing treatment strategies of hospitalized patients characterized by positive symptom.
The hospitalized patients characterized by positive symptom with acute schizophrenia episode were recruited. At the time of enrollment, the demographic, symptomatic and laboratory data was collected. After the completion of the baseline assessment and examination, the patients were given aripiprazole. Clinical evaluation was performed at 1、2、4 and 8 weeks after treatment, including the therapeutic efficacy and adverse drug reactions ,and monitoring of laboratory data.
- Conditions
- Acute Schizophrenia Episode
- Being tested
- Aripiprazole
- Keywords
- Aripiprazole; Acute schizophrenia episode; positive symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Aripiprazole Orally Disintegrating Tablets; Bosiqing®
Doses were flexibly titrated to between 10 and 30 mg once daily based on the individual needs of the patient as determined by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| aripiprazole group | Experimental | Patients receive aripiprazole treatment Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS (positive and negative symptoms scale) total score
Change from baseline PANSS (positive and negative symptoms scale) total score at 8 weeks
Measured: baseline,8 weeks
PANSS positive score
Change from baseline PANSS positive score at 8 weeks
Measured: baseline,8 weeks
CGI-S (clinical general impression-severity)
Change from baseline CGI-S (clinical general impression-severity) at 8 weeks
Measured: baseline,8 weeks
Secondary outcomes (2)
PANSS negative score
Change from baseline PANSS negative score at 8 weeks
Measured: baseline,8 weeks
MSQ (Medication Satisfaction Questionnaire)score
MSQ score at each assessment time point
Measured: baseline,8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start1 Sep 2017
- Primary completion23 Jan 2020
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Schizophrenia EpisodeStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 770 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si Tianmei, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289026
- Sponsor's protocol ID
- 320-57-1706-1101-0001
- Status last verified
- Feb 2021
- First submitted
- 17 Sep 2017
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study to Evaluate the Effectiveness and Safety of Aripiprazole in Patients With Acute Episode of Schizophrenia
- ClinicalTrials.gov ID
- NCT03289026
- Acronym / sponsor ID
- 320-57-1706-1101-0001
- Conditions
- Acute Schizophrenia Episode
- Keywords
- Aripiprazole; Acute schizophrenia episode; positive symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 770 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 20 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 attempts to observe the effectiveness and safety of aripiprazole in hospitalized patients with acute schizophrenia episode, and to compare the different drug regimens that may be involved in order to clarify the characteristics of the population for taking aripiprazole and provide reference for clinical rational drug use.
Detailed description
The control of acute schizophrenia effectively and rapidly will build up the confidence of patients on treatments. These early effects may influence the long-term compliance and prognosis of patients. Aripiprazole is an important drug in first line treatment of schizophrenia. However, at present in China, the application of aripiprazole in some patients with acute schizophrenia is not appropriate, leading to poor control of the positive symptoms of the acute phase.
The purpose of this single-arm, open-label trial is to study the situation of the use of aripiprazole in hospitalized patients with acute schizophrenia episode, and to compare the different drug regimens that may be involved in order to supply important information for optimizing treatment strategies of hospitalized patients characterized by positive symptom.
The hospitalized patients characterized by positive symptom with acute schizophrenia episode were recruited. At the time of enrollment, the demographic, symptomatic and laboratory data was collected. After the completion of the baseline assessment and examination, the patients were given aripiprazole. Clinical evaluation was performed at 1、2、4 and 8 weeks after treatment, including the therapeutic efficacy and adverse drug reactions ,and monitoring of laboratory data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aripiprazole group | Experimental | Drug: AripiprazolePatients receive aripiprazole treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients meeting International Classification of Diseases (tenth version, ICD-10) criteria for schizophrenia.
- acute episode; inpatients
- Age from 18-65 years old (inclusion), male or female
- PANSS total score at least 70
- scoring ≥ 4 on at least two of the following PANSS items: P1 (delusions), P2 (conceptual disorganisation), P3 (hallucinations), P6 (suspiciousness/persecution) ; and PANSS positive score is higher than PANSS negative score
Key exclusion criteria (13 listed)
- other serious diseases;
- Pregnant or breast feeding women or planning a pregnancy
- Patients in a state of drug-induced malignant syndrome or serious extrapyramidal side effect, or with a history of malignant syndrome or serious extrapyramidal side effect;
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Allergy to Aripiprazole
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 |
|---|---|---|
| AripiprazoleAlso: Aripiprazole Orally Disintegrating Tablets; Bosiqing®Doses were flexibly titrated to between 10 and 30 mg once daily based on the individual needs of the patient as determined by the investigator. | Drug | aripiprazole group |
Primary outcome
PANSS (positive and negative symptoms scale) total score
Time frame: baseline,8 weeks
Change from baseline PANSS (positive and negative symptoms scale) total score at 8 weeks
PANSS positive score
Time frame: baseline,8 weeks
Change from baseline PANSS positive score at 8 weeks
CGI-S (clinical general impression-severity)
Time frame: baseline,8 weeks
Change from baseline CGI-S (clinical general impression-severity) at 8 weeks
2 secondary outcomes
PANSS negative score
Time frame: baseline,8 weeks
MSQ (Medication Satisfaction Questionnaire)score
Time frame: baseline,8 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 5 Feb 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
12 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 Aripiprazole in people with Acute Schizophrenia Episode, run by Peking University at 12 sites 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 6 inclusion and 13 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 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 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?
PANSS (positive and negative symptoms scale) total score (time frame: baseline,8 weeks). The study lists 3 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 5 Feb 2021.