Strategic Use of New Generation Antidepressants for Depression
NCT ID: NCT01109693
Last Updated: 2016-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
2011 participants
INTERVENTIONAL
2010-12-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Continue sertraline
Continue sertraline at the dosage at 3 weeks
Sertraline
Sertraline 50 mg/d or 100 mg/d for 6 more weeks
Augment with mirtazapine
Add mirtazapine to sertraline
Sertraline
Sertraline 50 mg/d or 100 mg/d for 6 more weeks
Mirtazapine
Augment with or switch to mirtazapine 15-45 mg/d
Switch to mirtazapine
Stop sertraline and switch to mirtazapine
Mirtazapine
Augment with or switch to mirtazapine 15-45 mg/d
Interventions
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Sertraline
Sertraline 50 mg/d or 100 mg/d for 6 more weeks
Mirtazapine
Augment with or switch to mirtazapine 15-45 mg/d
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
25 Years
75 Years
ALL
No
Sponsors
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National Center of Neurology and Psychiatry, Japan
OTHER
Kyoto University
OTHER
Responsible Party
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Toshiaki A. Furukawa
Professor
Principal Investigators
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Toshiaki A Furukawa, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kyoto University Graduate School of Medicine / School of Public Health
Tatsuo Akechi, MD, PhD
Role: STUDY_DIRECTOR
Nagoya City University Graduate School of Medical Sciences
Norio Watanabe, MD, PhD
Role: STUDY_DIRECTOR
National Center of Neurology and Psychiatry, Japan
Shinji Shimodera, MD, PhD
Role: STUDY_DIRECTOR
Kochi University Medical School
Mitsuhiko Yamada, MD, PhD
Role: STUDY_DIRECTOR
National Center of Neurology and Psychiatry, Japan
Masatoshi Inagaki, MD, PhD
Role: STUDY_DIRECTOR
Okayama University Graudate School of Medicine
Naohiro Yonemoto, MSc
Role: STUDY_DIRECTOR
National Center of Neurology and Psychiatry, Japan
Kazuhira Miki, MD, PhD
Role: STUDY_DIRECTOR
Miki Mental Clinic, Yokohama, Japan
Locations
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Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Kochi Medical School Hospital
Nangoku, Kochi, Japan
Countries
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References
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Kato T, Furukawa TA, Mantani A, Kurata K, Kubouchi H, Hirota S, Sato H, Sugishita K, Chino B, Itoh K, Ikeda Y, Shinagawa Y, Kondo M, Okamoto Y, Fujita H, Suga M, Yasumoto S, Tsujino N, Inoue T, Fujise N, Akechi T, Yamada M, Shimodera S, Watanabe N, Inagaki M, Miki K, Ogawa Y, Takeshima N, Hayasaka Y, Tajika A, Shinohara K, Yonemoto N, Tanaka S, Zhou Q, Guyatt GH; SUN☺D Investigators. Optimising first- and second-line treatment strategies for untreated major depressive disorder - the SUN☺D study: a pragmatic, multi-centre, assessor-blinded randomised controlled trial. BMC Med. 2018 Jul 11;16(1):103. doi: 10.1186/s12916-018-1096-5.
Yonemoto N, Tanaka S, Furukawa TA, Kato T, Mantani A, Ogawa Y, Tajika A, Takeshima N, Hayasaka Y, Shinohara K, Miki K, Inagaki M, Shimodera S, Akechi T, Yamada M, Watanabe N, Guyatt GH; SUN(;_;)D Investigators. Strategic use of new generation antidepressants for depression: SUN(;_;) D protocol update and statistical analysis plan. Trials. 2015 Oct 14;16:459. doi: 10.1186/s13063-015-0985-6.
Shimodera S, Kato T, Sato H, Miki K, Shinagawa Y, Kondo M, Fujita H, Morokuma I, Ikeda Y, Akechi T, Watanabe N, Yamada M, Inagaki M, Yonemoto N, Furukawa TA; SUN(;_;)D Investigators. The first 100 patients in the SUN(;_;)D trial (strategic use of new generation antidepressants for depression): examination of feasibility and adherence during the pilot phase. Trials. 2012 Jun 8;13:80. doi: 10.1186/1745-6215-13-80.
Furukawa TA, Akechi T, Shimodera S, Yamada M, Miki K, Watanabe N, Inagaki M, Yonemoto N. Strategic use of new generation antidepressants for depression: SUN(;_;)D study protocol. Trials. 2011 May 11;12:116. doi: 10.1186/1745-6215-12-116.
Other Identifiers
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sun-d
Identifier Type: -
Identifier Source: org_study_id
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