UMIN-CTR Clinical Trial

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
Email	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
Email	hayashi@medcare-tora.com

Sponsor
Institute	Medical Care Toranomon
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041389