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Strategic Use of New Generation Antidepressants for Depression (SUN(^_^)D)

Primary Purpose

Unipolar Major Depressive Episode

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Sertraline
Mirtazapine
Sponsored by
Kyoto University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unipolar Major Depressive Episode

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nagoya City University Hospital
  • Kochi Medical School Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Continue sertraline

Augment with mirtazapine

Switch to mirtazapine

Arm Description

Continue sertraline at the dosage at 3 weeks

Add mirtazapine to sertraline

Stop sertraline and switch to mirtazapine

Outcomes

Primary Outcome Measures

Observer-rated depression severity (PHQ-9)
Personal Health Questionnaire-9 is a 9-item structured interview to measure depression severity. It will be rated by blinded telephone interview.

Secondary Outcome Measures

Self-rated depression severity (BDI-II)
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)
FIBSER stands for Frequency, Intensity and Burden of Side Effects Rating, which is an observer-rated global rating of side effects.

Full Information

First Posted
April 21, 2010
Last Updated
September 29, 2016
Sponsor
Kyoto University
Collaborators
National Center of Neurology and Psychiatry, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT01109693
Brief Title
Strategic Use of New Generation Antidepressants for Depression
Acronym
SUN(^_^)D
Official Title
Strategic Use of New Generation Antidepressants for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyoto University
Collaborators
National Center of Neurology and Psychiatry, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unipolar Major Depressive Episode

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2011 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continue sertraline
Arm Type
Active Comparator
Arm Description
Continue sertraline at the dosage at 3 weeks
Arm Title
Augment with mirtazapine
Arm Type
Active Comparator
Arm Description
Add mirtazapine to sertraline
Arm Title
Switch to mirtazapine
Arm Type
Active Comparator
Arm Description
Stop sertraline and switch to mirtazapine
Intervention Type
Drug
Intervention Name(s)
Sertraline
Intervention Description
Sertraline 50 mg/d or 100 mg/d for 6 more weeks
Intervention Type
Drug
Intervention Name(s)
Mirtazapine
Intervention Description
Augment with or switch to mirtazapine 15-45 mg/d
Primary Outcome Measure Information:
Title
Observer-rated depression severity (PHQ-9)
Description
Personal Health Questionnaire-9 is a 9-item structured interview to measure depression severity. It will be rated by blinded telephone interview.
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Self-rated depression severity (BDI-II)
Description
Beck Depression Inventory-II is a 21-item self-report of depression severity. It will be filled in by the patients themselves.
Time Frame
9 weeks
Title
Global rating of side effects (FIBSER)
Description
FIBSER stands for Frequency, Intensity and Burden of Side Effects Rating, which is an observer-rated global rating of side effects.
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshiaki A Furukawa, MD, PhD
Organizational Affiliation
Kyoto University Graduate School of Medicine / School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tatsuo Akechi, MD, PhD
Organizational Affiliation
Nagoya City University Graduate School of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Norio Watanabe, MD, PhD
Organizational Affiliation
National Center of Neurology and Psychiatry, Japan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shinji Shimodera, MD, PhD
Organizational Affiliation
Kochi University Medical School
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mitsuhiko Yamada, MD, PhD
Organizational Affiliation
National Center of Neurology and Psychiatry, Japan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Masatoshi Inagaki, MD, PhD
Organizational Affiliation
Okayama University Graudate School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Naohiro Yonemoto, MSc
Organizational Affiliation
National Center of Neurology and Psychiatry, Japan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kazuhira Miki, MD, PhD
Organizational Affiliation
Miki Mental Clinic, Yokohama, Japan
Official's Role
Study Director
Facility Information:
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Kochi Medical School Hospital
City
Nangoku
State/Province
Kochi
ZIP/Postal Code
783-8505
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29991347
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.
Results Reference
derived
PubMed Identifier
26466684
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.
Results Reference
derived
PubMed Identifier
22682213
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.
Results Reference
derived
PubMed Identifier
21569309
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.
Results Reference
derived

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Strategic Use of New Generation Antidepressants for Depression

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