UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050885 |
|---|---|
| Receipt number | R000057436 |
| Scientific Title | Intervention study on the combined effect of cognitive remediation therapy and exercise therapy for schizophrenia patients |
| Date of disclosure of the study information | 2023/04/19 |
| Last modified on | 2023/04/19 13:51:57 |
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Basic information
Public title
Intervention study on the combined effect of cognitive remediation therapy and exercise therapy for schizophrenia patients
Acronym
Intervention study on the combined effect of cognitive remediation therapy and exercise therapy for schizophrenia patients
Scientific Title
Intervention study on the combined effect of cognitive remediation therapy and exercise therapy for schizophrenia patients
Scientific Title:Acronym
Intervention study on the combined effect of cognitive remediation therapy and exercise therapy for schizophrenia patients
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the combined effect of cognitive remedial therapy and exercise therapy (aerobic exercise) on patients with schizophrenia, with neurocognitive and social-cognitive function as the primary endpoint. In addition, the possibility of clinical application of the retinal layer as a therapeutic effect prediction biomarker will be examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Evaluation of neurocognitive/social cognition function: The Brief Assessment of Cognition in Schizophrenia Japanese version (BACS.J), Social Cognition Screening Questionnaire Japanese version (SCSQ.J)
(2) Psychiatric symptoms assessment: Global Assessment of Functioning (GAF), Positive and Negative Syndrome Scale (PANSS)
(3) Evaluation of quality of life (QOL): Schizophrenia Quality of Life Scale Japanese version (SQLS.J)
(4) Retinal layers: Measure the retinal nerve fiber layer (RNFL), ganglion cell layer complex (GCC), macular volume, macular thickness, etc by SD-OCT. Implemented only at Tohoku University Hospital.
(5) Evaluation of Body composition: body fat percentage, muscle mass, basal metabolic rate, etc. (measured by body composition meter)
Key secondary outcomes
1) Evaluation of self-stigma: The Internalized Stigma of Illness Scale, Japanese version (ISMI.J)
2) Evaluation of personality tendency: Ten Item Personality Inventory Japanese versions (TIPI.J), The Autism-Spectrum Quotient Japanese versions (AQ.J)
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
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Intervention: Cognitive remedial therapy (NEAR) + exercise therapy (aerobic exercise) + usual treatment group
Interventions/Control_2
Control: Cognitive remedial therapy (NEAR) + usual treatment group
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients with schizophrenia who are outpatients at Tohoku University Hospital Psychiatry Department and Miyagi Psychiatric Medical Center
(2) Subjects who have been successfully treated with drugs and judged by the attending psychiatrist to be in a state of no significant hallucinations or delusions. Any stage is acceptable.
(3) Age between 20 and 40 (at the time of registration). IQ>70
(4) Regardless of gender
(5)Patients who have given their voluntary written consent after receiving a sufficient explanation for participating in this study.
(6) Patients who are already registered with daycare in both hospitals or who are considering registration with daycare and who are judged by attending psychiatrists to require treatment at daycare.
Key exclusion criteria
(1) Those who have a medical history or undergoing treatment at the time of first registration as follows; substance dependence, head injury, lifestyle-related diseases (hypertension, hyperlipidemia, diabetes), or vascular disorders (brain, cardiac, etc.), eye disease (cataract, glaucoma, etc.) or severe visual impairment (myopia, hyperopia, etc.), diagnosis of dementia, or those who score 21 points or less on the cognitive function evaluation MMSE (Mini-Mental State Examination).
(2) Subjects whose exercise is restricted by a doctor for some reason (orthopedic or medical reasons) at the time of first registration.
(3)Patients judged by the attending psychiatrist to be significantly lacking in consent due to marked hallucinations/delusions or thought disorders.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Tomita |
Organization
Graduate School of Medicine, Tohoku University
Division name
Department of Psychiatry
Zip code
980-8575
Address
2-1 Seiryo-Machi, Aoba-ku, Sendai, Japan
TEL
022-717-7262
htomita@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Komatsu |
Organization
Tohoku University Hospital
Division name
Department of Psychiatry
Zip code
980-8574
Address
1-1 Seiryo-Machi, Aoba-ku, Sendai, Japan
TEL
022-717-7262
Homepage URL
hkomatsu1019@gmail.com
Sponsor or person
Institute
Department of Psychiatry, Tohoku University Hospital
Department of Psychiatry, Graduate School of Medicine, Tohoku University
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
Japan
Other related organizations
Co-sponsor
Miyagi Psychiatric Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 04 | Month | 19 | Day |
Last modified on
| 2023 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057436
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