UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Adding smartphone cognitive-behavior therapy to pharmacotherapy for major depression: A randomized control trial
Title of the study (Brief title)	FLATT1
Region	Japan

Condition
Condition	Major depressive disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the value of adding smartphone cognitive-behavior therapy to pharmacotherapy for major depression
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Slope of Patient Health Questionnaire-9 (PHQ-9) scores at 0, 1, 5 and 9 weeks
Key secondary outcomes	Slope of Beck Depression Inventory-II (BDI-II) scores at 0, 1, 5 and 9 weeks, Response rate at 9 weeks (defined as 4 or less on PHQ-9) Treatment satisfaction at 9 weeks Continuation of antidepressant pharmacotherapy through 9 weeks Slope of Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scores at 0, 1, 5 and 9 weeks

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Other
Interventions/Control_1	smartphone cognitive-behavior therapy in addition to switch to escitalopram 5-10 mg/day or sertraline 25-100 mg/day
Interventions/Control_2	Switch to escitalopram 5-10 mg/day or sertraline 25-100 mg/day
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	25 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Age between 25 and 59, of both sexes 2) Primary diagnosis is major depressive disorder (DSM-5) 3) Pharmacotherapy-resistant, as confirmed by no to partial response to one or more antidepressants at adequate dose for four or more weeks and scoring 10 or more on BDI-II 4) Antidepressant as monotherapy with no concomitant antipsychotic or mood stabilizer 5) Indication for smartphone CBT according to treating physician 6) Adequate knowledge of smartphone 7) Outpatient at enrollment
Key exclusion criteria	1) Treatment with monoamine oxidase inhibitors, electroconvulsive therapy , repetitive transcranial magnetic stimulation, escitalopram/sertraline or individual face-to-face cognitive-behavior or interpersonal therapy during the index episode 2) Psychiatric omorbidities 2-1) Lifetime diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder 2-2) Current diagnosis of neurocognitive disorder, eating disorder, substance dependence or borderline personality disorder 3) Imminent risk of suicide 4) Physical comorbidities that interfere with escitalopram treatment 4-1) prolonged QTc (>450 ms for men, and >470 for women) 4-2) co-administration of drugs known to cause QTc prolongation as judged by treating physician 5) Pregnant or breast-feeding women 6) Current participation in another clinical intervention research
Target sample size	164

Research contact person
Name of lead principal investigator	Toshiaki A. Furukawa
Organization	Kyoto University Graduate School of Medicine / School of Public Health
Division name	Dept of Health Promotion and Human Behavior
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL	075-753-9491
Email	furukawa@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Toshiaki A. Furukawa
Organization	Kyoto University Graduate School of Medicine / School of Public Health
Division name	Dept of Health Promotion and Human Behavior
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL	075-753-9491
Homepage URL
Email	furukawa@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Japan Foundation of Neuroscience and Mental Health
Institute
Department

Funding Source
Organization	Japan Foundation of Neuroscience and Mental Health
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	名古屋市立大学病院（愛知県）、早稲田クリニック（愛知県）、高知大学医学部附属病院（高知県）、愛宕病院（高知県）、北海道大学病院（北海道）、新さっぽろメンタルクリニック（北海道）、北大通こころのクリニック（北海道）、東邦大学大森病院（東京都）、東邦大学大橋病院（東京都）、銀座泰明クリニック（東京都）、あらたまこころのクリニック（愛知県）、志岐クリニック（愛知県）、鳴海ひまわりクリニック（愛知県）、船山メンタルクリニック（愛知県）、広島大学病院（広島県）、まんたに心療内科（広島県）、草津病院（広島県）、呉医療センター（広島県）

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 04 Month 04 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date	2016 Year 10 Month 31 Day
Date of closure to data entry	2016 Year 10 Month 31 Day
Date trial data considered complete	2016 Year 12 Month 31 Day
Date analysis concluded	2017 Year 06 Month 30 Day

Related information
URL releasing protocol	http://www.ncbi.nlm.nih.gov/pubmed/26149441
Publication of results	Published
URL releasing results	http://www.jmir.org/2017/11/e373/
Results	Please see: Mantani A, Kato T, Furukawa TA, Horikoshi M, Imai H, Hiroe T, Chino B, Funayama T, Yonemoto N, Zhou Q & Kawanishi N (2017) Smartphone Cognitive Behavioral Therapy as an Adjunct to Pharmacotherapy for Refractory Depression: Randomized Controlled Trial. Journal of Medical Internet Research, 19, e373.
Other related information	The following secondary papers have been published: Furukawa TA, Horikoshi M, Fujita H, Tsujino N, Jinnin R, Kako Y, Ogawa S, Sato H, Kitagawa N, Shinagawa Y, Ikeda Y, Imai H, Tajika A, Ogawa Y, Akechi T, Yamada M, Shimodera S, Watanabe N, Inagaki M & Hasegawa A (in press) How do patients with major depression use and benefit from smartphone CBT? Content analyses of completed cognitive and behavioral skills exercises with Kokoro-app. JMIR Mental Health.

Management information
Registered date	2014 Year 04 Month 11 Day
Last modified on	2017 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015984