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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010827
Receipt No. R000012657
Scientific Title Comparative effect of second-generation antipsychotic blonanserin and aripiprazole on cognitive impairment in first-episode schizophrenia: An open-label trial
Date of disclosure of the study information 2013/06/01
Last modified on 2016/03/08

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Basic information
Public title Comparative effect of second-generation antipsychotic blonanserin and aripiprazole on cognitive impairment in first-episode schizophrenia: An open-label trial
Acronym Effect of second-generation antipsychotics on cognition in first-episode schizophrenia
Scientific Title Comparative effect of second-generation antipsychotic blonanserin and aripiprazole on cognitive impairment in first-episode schizophrenia: An open-label trial
Scientific Title:Acronym Effect of second-generation antipsychotics on cognition in first-episode schizophrenia
Region
Japan

Condition
Condition schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Broad cognitive domains are impaired in approximately 85% of patients with schizophrenia and cognitive deficits are considered to be a core feature of the disease. Cognitive impairments appear from early stage and have become an important therapeutic target for pharmacotherapy. The purpose of this study is to evaluate the effects of blonanserin and aripiprazole on cognitive function in antipsychotic-naive first-episode schizophrenia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Cognitive function: Brief Assessment of Cognition in Schizophrenia-Japanese version (BACS-J)
Key secondary outcomes Psychopathology: Positive And Negative Syndrome Scale (PANSS), Clinical Global Impression- Severity (CGI-S)
Functional ability: Schizophrenia Cognitive Rating Scale- Japanese version (SCoRS-J), University of California, San Diego, Performance- Based Skills Assessment (UPSA)
Subjective assessments: Schizophrenia Quality of Life Scale-Japanese version (SQLS-J), Subjective Well-being under Neuroleptic drug treatment Short form, Japanese version (SWNS-J)
Adverse effects: Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS),Weight
Laboratory tests

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 First-episode schizophrenia; blonanserin treatment group

Patients were received blonanserin, and the dosage is adjusted to between 2 and 24 mg/day.
Interventions/Control_2 Control group

Chronic patients with schizophrenia who were treated with a stable dose of blonanserin for at least 12 weeks.
Interventions/Control_3 First-episode schizophrenia; aripiprazole treatment group

Patients were received aripiprazole, and the dosage is adjusted to between 3 and 30 mg/day.
Interventions/Control_4 Control group

Chronic patients with schizophrenia who were treated with a stable dose of aripiprazole for at least 12 weeks.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
40 years-old >=
Gender Male and Female
Key inclusion criteria 1) aged 16 to 40 years
2) meeting DSM-IV-TR criteria for schizophrenia, schizophreniform disorder, or schizoaffective disorder
3) experiencing their first episode of psychosis for at least 1 month and less than 5 years
4) no history of antipsychotic exposure or, if previously treated, a total lifetime of antipsychotic treatment of less than 16 weeks, and no antipsychotic administration for 12 weeks before participating in the study
5)inpatient or outpatient
6) patients who gave informed consent
Key exclusion criteria 1) patients who had been treated with blonanserin or aripiprazole before study entry
2) comorbid central nervous system disorder
3) meeting DSM-IV-TR criteria for alcohol or other substance dependence
4) meeting DSM-IV-TR criteria for mental retardation
5) symptomatic or organic psychosis (including dementia)
6) taking tricyclic antidepressants
7) treatment with electroconvulsive therapy in the 12 weeks preceding the study
8) treatment with long-acting antipsychotics in the 12 weeks preceding the study
9) patients who are not voluntarily hospitalized
10) active expression of suicidal or homicidal ideation
11) pregnancy or breast feeding
12) inability to understand the study protocol
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiya Miyamoto
Organization St. Marianna University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511
TEL 044-977-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomomi Tenjin
Organization St. Marianna University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511
TEL 044-977-8111
Homepage URL
Email t2tenjin@marianna-u.ac.jp

Sponsor
Institute Department of Neuropsychiatry
St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization Department of Neuropsychiatry
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Ofuji hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 聖マリアンナ医科大学神経精神科学教室(神奈川県)Department of Neuropsychiatry
St. Marianna University School of Medicine (Kanagawa)
大富士病院(静岡県) Ofuji hospital (Shizuoka)

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2013 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2016 Year 01 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 08 Day
Date trial data considered complete
2016 Year 03 Month 08 Day
Date analysis concluded
2016 Year 03 Month 08 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 29 Day
Last modified on
2016 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012657

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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