Clinical trial NCT01109693: Strategic Use of New Generation Antidepressants for Depression
Official title: Strategic Use of New Generation Antidepressants for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Unipolar Major Depressive Episode
Lead sponsor: Kyoto University Hospital
Sponsor class: OTHER
Collaborators: name: National Center of Neurology and Psychiatry, Japan
First posted: 2010-04-23
Enrollment: 2011
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Observer-rated depression severity (PHQ-9)
timeFrame: 9 weeks
Secondary outcomes:
measure: Self-rated depression severity (BDI-II)
timeFrame: 9 weeks
measure: Global rating of side effects (FIBSER)
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Nangoku
country: Japan
facility: Kochi Medical School Hospital
state: Kochi
Study officials:
affiliation: Kyoto University Graduate School of Medicine / School of Public Health
name: Toshiaki A Furukawa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nagoya City University Graduate School of Medical Sciences
name: Tatsuo Akechi, MD, PhD
role: STUDY_DIRECTOR
affiliation: National Center of Neurology and Psychiatry, Japan
name: Norio Watanabe, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kochi University Medical School
name: Shinji Shimodera, MD, PhD
role: STUDY_DIRECTOR
affiliation: National Center of Neurology and Psychiatry, Japan
name: Mitsuhiko Yamada, MD, PhD
role: STUDY_DIRECTOR
affiliation: Okayama University Graudate School of Medicine
name: Masatoshi Inagaki, MD, PhD
role: STUDY_DIRECTOR
affiliation: National Center of Neurology and Psychiatry, Japan
name: Naohiro Yonemoto, MSc
role: STUDY_DIRECTOR
affiliation: Miki Mental Clinic, Yokohama, Japan
name: Kazuhira Miki, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.