Unique ID issued by UMIN | UMIN000029782 |
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Receipt number | R000034028 |
Scientific Title | Strategic Use of New generation antidepressants for Depression |
Date of disclosure of the study information | 2017/11/01 |
Last modified on | 2024/03/18 15:12:44 |
Strategic Use of New generation antidepressants for Depression
SUN(^_^)D
Strategic Use of New generation antidepressants for Depression
SUN(^_^)D
Japan |
Major depression
Psychiatry |
Others
NO
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.
Efficacy
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.
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.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
3
Treatment
Medicine |
Continue sertraline
Augment sertraline with mirtazapine
Switch to mirtazapine
25 | years-old | <= |
75 | years-old | >= |
Male and Female
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
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
2000
1st name | |
Middle name | |
Last name | Toshi A. Furukawa |
Kyoto University Graduate School of Medicine / School of Public Health
Department of Health Promotion and Human Behavior
Yoshida Konoe-cho, Sakyo-ku, Kyoto
075-753-9491
furukawa@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Mitsuhiko Yamada |
National Center of Neurology and Psychiatry
Department of Neuropsychopharmacology
Higashi-cho 4-1, Kodaira, Tokyo
042-346-9519
mitsu@ncnp.go.jp
Steering Committee of SUN(^_^)D
Japan Foundation for Neuroscience and Mental Health
Non profit foundation
YES
NCT01109693
clinicaltrial.gov
JapicCTI-101199
Japic
2017 | Year | 11 | Month | 01 | Day |
https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-12-116
Published
https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-018-1096-5
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.
Main results already published
2010 | Year | 04 | Month | 22 | Day |
2010 | Year | 08 | Month | 30 | Day |
2010 | Year | 12 | Month | 01 | Day |
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 03 | Month | 31 | Day |
2018 | Year | 06 | Month | 06 | Day |
2017 | Year | 11 | Month | 01 | Day |
2024 | Year | 03 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034028
Research Plan | |
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Registered date | File name |
2017/11/02 | _1研究プロトコル_2017-10-01.docx |
Research case data specifications | |
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Registered date | File name |
2017/11/15 | Table of variable definitions.xlsx |
Research case data | |
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Registered date | File name |
2017/11/15 | Datasets in csv.zip |