UMIN-ICDR Clinical Trial

Basic information
Public title	Strategic Use of New generation antidepressants for Depression
Acronym	SUN(^_^)D
Scientific Title	Strategic Use of New generation antidepressants for Depression
Scientific Title:Acronym	SUN(^_^)D
Region	Japan

Condition
Condition	Major depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the study is to establish the optimum treatment strategy for first-line and second-line antidepressants in the acute phase treatment of major depression.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Observer-rated depression severity (PHQ-9) [ Time Frame: 9 weeks ] Personal Health Questionnaire-9 is a 9-item structured interview to measure depression severity. It will be rated by blinded telephone interview.
Key secondary outcomes	Self-rated depression severity (BDI-II) [ Time Frame: 9 weeks ] Beck Depression Inventory-II is a 21-item self-report of depression severity. It will be filled in by the patients themselves. Global rating of side effects (FIBSER) [ Time Frame: 9 weeks ] FIBSER stands for Frequency, Intensity and Burden of Side Effects Rating, which is an observer-rated global rating of side effects.

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	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Continue sertraline
Interventions/Control_2	Augment sertraline with mirtazapine
Interventions/Control_3	Switch to mirtazapine
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	non-psychotic unipolar major depressive episode (Diagnostic and Statistical Manual, Fourth Edition [DSM-IV]) in the preceding month age 25-75 starting treatment with sertraline clinically indicated tolerability to sertraline 25 mg/d ascertained can understand and sign informed consent form can be contacted by telephone for symptom severity and adverse events
Key exclusion criteria	have received antidepressants, mood stabilizers, antipsychotics, psychostimulants, electroconvulsive therapy (ECT) or depression-specific psychotherapies in the preceding month history of schizophrenia, schizoaffective disorder or bipolar disorder current dementia, borderline personality disorder, eating disorder or substance dependence physical disease interfering with sertraline or mirtazapine treatment allergy to sertraline or mirtazapine terminal physical illness currently pregnant or breast-feeding high risk of imminent suicide requiring compulsory admission expected to change doctors within 6 months cohabiting relatives of research staff cannot understand Japanese
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toshi A. Furukawa
Organization	Kyoto University Graduate School of Medicine / School of Public Health
Division name	Department of Health Promotion and Human Behavior
Zip code
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL	075-753-9491
Email	furukawa@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Mitsuhiko Yamada
Organization	National Center of Neurology and Psychiatry
Division name	Department of Neuropsychopharmacology
Zip code
Address	Higashi-cho 4-1, Kodaira, Tokyo
TEL	042-346-9519
Homepage URL
Email	mitsu@ncnp.go.jp

Sponsor
Institute	Steering Committee of SUN(^_^)D
Institute
Department

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

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT01109693
Org. issuing International ID_1	clinicaltrial.gov
Study ID_2	JapicCTI-101199
Org. issuing International ID_2	Japic
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 01 Day

Related information
URL releasing protocol	https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-12-116
Publication of results	Published

Result
URL related to results and publications	https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-018-1096-5
Number of participants that the trial has enrolled
Results	Between December 2010 and March 2015, we recruited 2,011 participants with hitherto untreated major depression at 48 clinics in Japan. In Step 1, 970 participants were allocated to the 50 mg/day and 1,041 to the 100 mg/day arms; 1,927 (95.8%) provided primary outcomes. There was no statistically significant difference in the adjusted PHQ-9 score at week 9 between the 50 mg/day arm and the 100 mg/day arm (0.25 points 95% CI, -0.58 to 1.07, P=0.55). Other outcomes proved similar in the two groups. In Step 2, 1,646 participants not remitted by week 3 were randomised to continue sertraline (n=551), to add mirtazapine (n=537), or to switch to mirtazapine (n=558): 1,613 (98.0%) provided primary outcomes. At week 9, adding mirtazapine achieved a reduction in PHQ-9 scores of 0.99 points (0.43 to 1.55, P=0.0012); switching achieved a reduction of 1.01 points (0.46 to 1.56, P=0.0012), both relative to continuing sertraline. Combination increased the percentage of remission by 12.4% (6.1% to 19.0%) and switching by 8.4% (2.5% to 14.8%). There were no differences in adverse effects.
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	Main results already published
Date of protocol fixation	2010 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date	2010 Year 12 Month 01 Day
Last follow-up date	2015 Year 09 Month 30 Day
Date of closure to data entry	2015 Year 11 Month 30 Day
Date trial data considered complete	2015 Year 11 Month 30 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 11 Month 01 Day
Last modified on	2018 Year 08 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034028

Research Plan
Registered date	File name
2017/11/02	_1研究プロトコル_2017-10-01.docx

Research case data specifications
Registered date	File name
2017/11/15	Table of variable definitions.xlsx

Research case data
Registered date	File name
2017/11/15	Datasets in csv.zip

Contact us.