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UMIN-ICDR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Major depression | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 2000 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |