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Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients

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Sumitomo Pharma

Status and phase

Terminated
Phase 4

Conditions

Blonanserin
Social Function
First Episode Schizophrenia
Cognition Function

Treatments

Other: MRI and serum BDNF
Drug: Blonanserin

Study type

Interventional

Funder types

Industry

Identifiers

NCT03784222
DSPCLON-002

Details and patient eligibility

About

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

Enrollment

102 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 2 patient groups

treatment group
Experimental group
Description:
188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test
Treatment:
Other: MRI and serum BDNF
Drug: Blonanserin
control group
Other group
Description:
60 subjects without schizophrenia, only receiving MRI and/or serum BDNF
Treatment:
Other: MRI and serum BDNF

Trial contacts and locations

8

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Central trial contact

Haiyun Li

Data sourced from clinicaltrials.gov

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