UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000029782 |
|---|---|
| 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 |
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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
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
mitsu@ncnp.go.jp
Sponsor or person
Institute
Steering Committee of SUN(^_^)D
Institute
Department
Personal name
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
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
| 2010 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/34028
