UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032806 |
|---|---|
| Receipt number | R000037423 |
| Scientific Title | The effect of compensatory cognitive training for patients with schizophrenia |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2019/04/12 16:52:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of compensatory cognitive training for patients with schizophrenia
Acronym
The effect of compensatory cognitive training for patients with schizophrenia
Scientific Title
The effect of compensatory cognitive training for patients with schizophrenia
Scientific Title:Acronym
The effect of compensatory cognitive training for patients with schizophrenia
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of Cognitive Remediation Therapy (CRT) focusing on the cognitive function problem in schizophrenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neuropsychological tests, clinical symptom measures, NIRS and BDNF at pre and post intervention
Key secondary outcomes
Neuropsychological tests, clinical symptom measures, NIRS and BDNF at 3 months after intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
CRT, once a week for 3 months
Interventions/Control_2
Non-CRT
Interventions/Control_3
Interventions/Control_4
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patient who meets ICD-10 criteria for schizophrenia
2) Patients whose condition is relatively stable
3) Patient who gave written informed consent
Key exclusion criteria
1) dependence on alcohol
2) Patients who are at high risk of violence, suicide attempts, impulsive acts
3) Patients with head trauma, cerebrovascular disorders and neurodegenerative diseases
4) Patients under 16 years of age
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Higuchi |
Organization
University of Toyama
Division name
Department of Neuropsychiatry
Zip code
930-0152
Address
2630 Sugitani, Toyama
TEL
076-434-7323
yhiguchi@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Nakada |
Organization
University of Toyama
Division name
Department of Neuropsychiatry
Zip code
930-0152
Address
2630 Sugitani, Toyama
TEL
076-434-7323
Homepage URL
noutore_toyama@yahoo.co.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyama university hospital Center for Clinical Research
Address
2630 Sugitani, Toyama
Tel
076-415-8857
rinri@adm.u-toyama.ac.jp
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
富山大学附属病院(富山県)、砺波サナトリウム福井病院(富山県)
Other administrative information
Date of disclosure of the study information
| 2018 | 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
41
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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 31 | Day |
Last modified on
| 2019 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037423
