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

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.

Study Overview

• Status: Completed
• Conditions: Unipolar Major Depressive Episode
• Intervention / Treatment: Drug: Sertraline; Drug: Mirtazapine

• Study Type: Interventional
• Enrollment (Actual): 2011
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya, Aichi, Japan, 467-8602
      • Nagoya City University Hospital
  • Kochi
    • Nangoku, Kochi, Japan, 783-8505
      • Kochi Medical School Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continue sertraline; Continue sertraline at the dosage at 3 weeks	Drug: Sertraline; Sertraline 50 mg/d or 100 mg/d for 6 more weeks
Active Comparator: Augment with mirtazapine; Add mirtazapine to sertraline	Drug: Sertraline; Sertraline 50 mg/d or 100 mg/d for 6 more weeks; Drug: Mirtazapine; Augment with or switch to mirtazapine 15-45 mg/d
Active Comparator: Switch to mirtazapine; Stop sertraline and switch to mirtazapine	Drug: Mirtazapine; Augment with or switch to mirtazapine 15-45 mg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 weeks
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.	9 weeks

Collaborators and Investigators

• Sponsor: Kyoto University
• Collaborators: National Center of Neurology and Psychiatry, Japan
• Investigators: Principal Investigator: Toshiaki A Furukawa, MD, PhD, Kyoto University Graduate School of Medicine / School of Public Health; Study Director: Tatsuo Akechi, MD, PhD, Nagoya City University Graduate School of Medical Sciences; Study Director: Norio Watanabe, MD, PhD, National Center of Neurology and Psychiatry, Japan; Study Director: Shinji Shimodera, MD, PhD, Kochi University Medical School; Study Director: Mitsuhiko Yamada, MD, PhD, National Center of Neurology and Psychiatry, Japan; Study Director: Masatoshi Inagaki, MD, PhD, Okayama University Graudate School of Medicine; Study Director: Naohiro Yonemoto, MSc, National Center of Neurology and Psychiatry, Japan; Study Director: Kazuhira Miki, MD, PhD, Miki Mental Clinic, Yokohama, Japan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 21, 2010
• First Submitted That Met QC Criteria: April 22, 2010
• First Posted (Estimate): April 23, 2010

Study Record Updates

• Last Update Posted (Estimate): October 3, 2016
• Last Update Submitted That Met QC Criteria: September 29, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Sertraline; Mirtazapine
• Other Study ID Numbers: sun-d