UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036468 |
|---|---|
| Receipt number | R000041389 |
| Scientific Title | The effects of aerobic exercise and computer-based cognitive training on depressive symptoms and cognitive function of major depressive disorder and bipolar disorder: a randomized, open-label, parallel group trial |
| Date of disclosure of the study information | 2019/04/15 |
| Last modified on | 2021/10/13 15:09:17 |
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Basic information
Public title
The effects of aerobic exercise and computer-based cognitive training on depressive symptoms and cognitive function of major depressive disorder and bipolar disorder: a randomized, open-label, parallel group trial
Acronym
The effects of aerobic exercise and computer-based cognitive training on depressive symptoms and cognitive function of MDD and BD
Scientific Title
The effects of aerobic exercise and computer-based cognitive training on depressive symptoms and cognitive function of major depressive disorder and bipolar disorder: a randomized, open-label, parallel group trial
Scientific Title:Acronym
The effects of aerobic exercise and computer-based cognitive training on depressive symptoms and cognitive function of MDD and BD
Region
| Japan |
Condition
Condition
Major depressive disorder
Bipolar disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of aerobic exercise and computer-based cognitive training on depressive symptoms and cognitive function in patients with major depressive disorder and bipolar disorder.
Basic objectives2
Others
Basic objectives -Others
Exploratory trial
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in BDI-2 score at 4week, 8week and 12week.
Key secondary outcomes
1)The rates of response and remission at 4week, 8week and 12week.
2)Change in MOS 36-Item Short-Form Health Survey(SF-36) at 4week, 8week and 12week.
3)Change in THINC-it score at 4week, 8week and 12week.
4) adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
none
Interventions/Control_2
aerobic exercise (20 min/day, twice /week, 12 weeks)
Interventions/Control_3
computer-based cognitive training(20 min/day, twice /week, 12 weeks)
Interventions/Control_4
aerobic exercise combined with computer-based cognitive training (20 min/day, twice /week, 12 weeks)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Major depressive episode of major depressive disorder or bipolar disorder defined by DSM-5
2) Patients treated with fixed regimen of medication and/or psychotherapy
3) Total Beck Depression Inventory 2 score >=15 at baseline
Key exclusion criteria
1) Patients with psychotic feature
2) Depression secondary to a general medical condition, or substance-induced
3) rapid cycling bipolar disorder
4) History of substance abuse or dependence within the past 6 months (except nicotine and caffeine)
5) Patients with contraindication for exercise therapy (ex orthopedic disease, cardiovascular disease)
6) Patients who have been exercising continuously within the past year
7) Present suicidal risk as assessed by the investigator or a tendency of attempted suicide in BDI-2 score
8)Any self-inflicted harm in the past
9)Women who are pregnant or breast-feeding
10) Patients undergoing computer-based cognitive training
Target sample size
336
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | |
| Last name | Sekiya |
Organization
Negishi Hospital
Division name
Department of Psychiatry
Zip code
1830042
Address
2-12-2 Musashidai, Fuchu-shi, Tokyo
TEL
042-572-4121
4.left.sekiya@gmail.com
Public contact
Name of contact person
| 1st name | Toshihide |
| Middle name | |
| Last name | Hayashi |
Organization
Medical Care Toranomon
Division name
Medical Care Toranomon
Zip code
1050001
Address
MG building 3F/4F, 1-16-16 Toranomon, Minato-ku, Tokyo
TEL
03-5510-3898
Homepage URL
hayashi@medcare-tora.com
Sponsor or person
Institute
Medical Care Toranomon
Institute
Department
Personal name
Funding Source
Organization
Medical Care Toranomon
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Association of Rework for Depression
Address
1-12-11 Toranomon, Minato-ku, Tokyo, Japan
Tel
03-5512-1161
hayashi@medcare-tora.com
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
| 2019 | Year | 04 | Month | 15 | 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
| 2018 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 04 | Month | 10 | Day |
Last modified on
| 2021 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041389
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