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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000029782
Receipt No. R000034028
Scientific Title Strategic Use of New generation antidepressants for Depression
Date of disclosure of the study information 2017/11/01
Last modified on 2018/08/16

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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://upload.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


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