UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010827 |
|---|---|
| Receipt number | 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 12:37:43 |
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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
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
t2tenjin@marianna-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry
St. Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012657
