First Episode SchizophreniaPhase 4NCT03784222
Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients
A Phase 4 study testing Blonanserin and MRI and serum BDNF in people with First Episode Schizophrenia and Social Function, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 8 sites in China.
Trial summary
This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- First Episode Schizophrenia, Social Function, Cognition Function
- What is being tested?
- Blonanserin and MRI and serum BDNF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 8 sitesChina
- Study dates
- 22 Jan 2019to 22 Nov 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Schizophrenia patients diagnosis either with DSM-5 criteria or ICD-10;
- PANSS total score ≥70;
- Males or Females aged 18-45 years;
- With disease course less than 5 years and during their first episode;
- ≥9 years of education;
- Without receiving systematic antipsychotic treatment, or receiving continuous antipsychotic treatment for less than 6 weeks and receiving antipsychotic treatment for less than 6 months in total;
- Ability to read and understand Chinese;
- Provision of written informed consent
Who cannot join
- Severe or unstable physical diseases judged by investigators;
- Loss of consciousness more than 1 hour due to any reason in the past 1 year;
- Current substance misuse (in 3 months) or any substance dependence;
- Pregnant or lactating woman;
- Patients with attempted suicide history, severe suicidal ideation or behaviour;
- Mental retardation;
Show all 19Show fewer
- Contradict to the study drugs;
- Patients taken other investigation products in the past 30 days before entry;
- Patients ever taken blonanserin before;
- Any current medical condition that would interfere with the assessment of efficacy;
- Physical symptoms of acute deterioration requiring hospitalization or increased intensive care;
- Significant muscle tension or Parkinson's disease;
- Clinically significant abnormal laboratory test results (blood, urine, and blood biochemical analysis);
- Clinically significant Abnormal electrocardiogram as judged by researchers;
- Participants continuously using sedative drugs, or anticholinergic agents within 3 months of the study;
- Those who had undergone electroconvulsive therapy within 3 month of the study;
- Those who had received long-acting injection treatment within 3 month of the study;
- Those who could not swallow medication with water;
- Subjects judged by the investigator in charge as inappropriate for the study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, 100096
Peking University Sixth Hospital
Beijing, Beijing Municipality
The Second Xiangya Hospital of Central South University
Changsha, Hunan
West China Hospital, Sichuan Univeristy
Chengdu, Sichuan
The First Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200000
Tianjin Mental Health Center
Tianjin, Tianjin Municipality
Xi'an Mental Health Center
Xi’an, Shanxi
About this study
This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients
- Being tested
- Blonanserin, MRI and serum BDNF
- Medical subject headings
- Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlonanserinDrug
patients were prescribed blonanserin 4-24mg/d according to the patients' response and tolerability
MRI and serum BDNFOther
60 patients receive MRI and serum BDNF test, 60 controls receive MRI, 20 of the 60 controls receive serum BDNF test
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | 188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test Receives: Drug: Blonanserin; Other: MRI and serum BDNF |
| control group | Other | 60 subjects without schizophrenia, only receiving MRI and/or serum BDNF Receives: Other: MRI and serum BDNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in personal and social performance (PSP) scores at week 26
PSP consists of four main areas: 1. Socially useful activities (e.g., housework, voluntary work) including work and study; 2. Personal and social relationships (i.e., partner, family relationships, friends); 3. Self-care (i.e., personal hygiene, care of one's appearance); 4. Disturbing and aggressive behavior. The maximum scores is 100, the minimum scores is 1, higher values represent a better outcome
Measured: 26 weeks
Secondary outcomes (7)
changes in MATRICS Consensus Cognitive Battery (MCCB) domain scores at week 26 in treatment group
MATRICS Consensus Cognitive Battery (MCCB) includes 10 tests that measure seven cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving and social cognition. Scores for the individual tests will be calculated according to the developer's recommended scoring algorithms
Measured: 26 weeks
changes in Paced Auditory Serial Addition Task (PASAT) test at week 26 in treatment group
PASAT is a neuropsychological test used to assess capacity and rate of information processing and sustained and divided attention
Measured: 26 weeks
changes in Groove Pegboard Test (GPT) at week 26 in treatment group
GPT is a test used to assess fine motor skills and speed. this test measure the time it takes to put 25 nails in the pegborad in a defined order
Measured: 26 weeks
changes in positive and negative syndrome scale (PANSS) total scores at week 26 in treatment group
PANSS is a medical scale used for measuring symptom severity of patients with schizophrenia. the maximum scores is 210, the minimum scores is 30. the higher values represent a worse outcome. the total scores are the sum of subscales.
Measured: 26 weeks
changes in PANSS five-factor model scores at week 26 in treatment group
five-factor model is another model of PANSS. It is a medical scale used for measuring symptom severity of patients with schizophrenia. the maximum scores is 210, the minimum scores is 30. the higher values represent a worse outcome. the total scores are the sum of subscales.
Measured: 26 weeks
changes in PSP at every visit in treatment group during 26 weeks
PSP consists of four main areas: 1. Socially useful activities (e.g., housework, voluntary work) including work and study; 2. Personal and social relationships (i.e., partner, family relationships, friends); 3. Self-care (i.e., personal hygiene, care of one's appearance); 4. Disturbing and aggressive behavior. The maximum scores is 100, the minimum scores is 1, higher values represent a better outcome
Measured: baseline, week 8, week 26
changes in MCCB at every visit in treatment group during 26 weeks
MATRICS Consensus Cognitive Battery (MCCB) includes 10 tests that measure seven cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving and social cognition. Scores for the individual tests will be calculated according to the developer's recommended scoring algorithms
Measured: baseline, week 8, week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start22 Jan 2019
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
Why it stopped: Company's business decision
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 First Episode 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xin Yu, MD, Principal investigator, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784222
- Sponsor's protocol ID
- DSPCLON-002
- Status last verified
- Apr 2024
- First submitted
- 28 Nov 2018
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pu C, Lei L, Yang F, Deng H, Sheng J, Liu Z, Hu S, Wang L, Wu B, Bo Q, Inoue Y, Yu X. Effectiveness and safety of blonanserin for improving social and cognitive functions in patients with first-episode schizophrenia: a study protocol for a prospective, multicentre, single-arm clinical trial. BMJ Open. 2022 Apr 20;12(4):e054079. doi: 10.1136/bmjopen-2021-054079.
PubMed 35443947
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT03784222
- Acronym / sponsor ID
- DSPCLON-002
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company's business decision
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 21 Dec 2018 (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 is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Blonanserin, Other: MRI and serum BDNF188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test |
| control group | Other | Other: MRI and serum BDNF60 subjects without schizophrenia, only receiving MRI and/or serum BDNF |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Schizophrenia patients diagnosis either with DSM-5 criteria or ICD-10;
- PANSS total score ≥70;
- Males or Females aged 18-45 years;
- With disease course less than 5 years and during their first episode;
- ≥9 years of education;
Key exclusion criteria (19 listed)
- Severe or unstable physical diseases judged by investigators;
- Loss of consciousness more than 1 hour due to any reason in the past 1 year;
- Current substance misuse (in 3 months) or any substance dependence;
- Pregnant or lactating woman;
- Patients with attempted suicide history, severe suicidal ideation or behaviour;
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 |
|---|---|---|
| Blonanserinpatients were prescribed blonanserin 4-24mg/d according to the patients' response and tolerability | Drug | treatment group |
| MRI and serum BDNF60 patients receive MRI and serum BDNF test, 60 controls receive MRI, 20 of the 60 controls receive serum BDNF test | Other | control group, treatment group |
Primary outcome
changes in personal and social performance (PSP) scores at week 26
Time frame: 26 weeks
PSP consists of four main areas: 1. Socially useful activities (e.g., housework, voluntary work) including work and study; 2. Personal and social relationships (i.e., partner, family relationships, friends); 3. Self-care (i.e., personal hygiene, care of one's appearance); 4. Disturbing and aggressive behavior. The maximum scores is 100, the minimum scores is 1, higher values represent a better outcome
7 secondary outcomes
changes in MATRICS Consensus Cognitive Battery (MCCB) domain scores at week 26 in treatment group
Time frame: 26 weeks
changes in Paced Auditory Serial Addition Task (PASAT) test at week 26 in treatment group
Time frame: 26 weeks
changes in Groove Pegboard Test (GPT) at week 26 in treatment group
Time frame: 26 weeks
changes in positive and negative syndrome scale (PANSS) total scores at week 26 in treatment group
Time frame: 26 weeks
changes in PANSS five-factor model scores at week 26 in treatment group
Time frame: 26 weeks
changes in PSP at every visit in treatment group during 26 weeks
Time frame: baseline, week 8, week 26
changes in MCCB at every visit in treatment group during 26 weeks
Time frame: baseline, week 8, week 26
Results and safety
The study was stopped early (reason given: Company's business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Derived from this study: PubMed 35443947Pu C, Lei L, Yang F, Deng H, Sheng J, Liu Z, Hu S, Wang L, Wu B, Bo Q, Inoue Y, Yu X. Effectiveness and safety of blonanserin for improving social and cognitive functions in patients with first-episode schizophrenia: a study protocol for a prospective, multicentre, single-arm clinical trial. BMJ Open. 2022 Apr 20;12(4):e054079. doi: 10.1136/bmjopen-2021-054079.
- 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.
Xin Yu, MD principal investigator
Peking University Sixth Hospital
8 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 Blonanserin and MRI and serum BDNF in people with First Episode Schizophrenia and Social Function, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 8 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 8 inclusion and 19 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: stopped early, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 was stopped early (reason given: Company's business decision). Results are not available in the source record.
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?
changes in personal and social performance (PSP) scores at week 26 (time frame: 26 weeks). 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 NCT03784222, 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 19 Apr 2024.