Clinical trial NCT03784222: Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients
Official title: Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: First Episode Schizophrenia
Social Function
Cognition Function
Blonanserin
Lead sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-12-21
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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;
* 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

Primary outcomes:
measure: changes in personal and social performance (PSP) scores at week 26
timeFrame: 26 weeks
Secondary outcomes:
measure: changes in MATRICS Consensus Cognitive Battery (MCCB) domain scores at week 26 in treatment group
timeFrame: 26 weeks
measure: changes in Paced Auditory Serial Addition Task (PASAT) test at week 26 in treatment group
timeFrame: 26 weeks
measure: changes in Groove Pegboard Test (GPT) at week 26 in treatment group
timeFrame: 26 weeks
measure: changes in positive and negative syndrome scale (PANSS) total scores at week 26 in treatment group
timeFrame: 26 weeks
measure: changes in PANSS five-factor model scores at week 26 in treatment group
timeFrame: 26 weeks
measure: changes in PSP at every visit in treatment group during 26 weeks
timeFrame: baseline, week 8, week 26
measure: changes in MCCB at every visit in treatment group during 26 weeks
timeFrame: baseline, week 8, week 26
Other outcomes:
measure: changes in magnetic resonance imaging (MRI) at week 26 in treatment group
timeFrame: 26 weeks
measure: changes in MRI at every visit in treatment group during 26 weeks
timeFrame: baseline, week 8, week 26
measure: difference of MRI results between treatment group and control group at baseline
timeFrame: baseline
measure: changes in serum Brain-derived neurotrophic factor (BDNF) at week 26 in treatment group
timeFrame: 26 weeks
measure: difference of serum BDNF results between treatment group and control group at baseline
timeFrame: baseline
Locations:
city: Beijing
country: China
facility: Beijing Huilongguan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Xi'an
country: China
facility: Xi'an Mental Health Center
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan Univeristy
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Mental Health Center
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Peking University Sixth Hospital
name: Xin Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.