Strategic Use of New Generation Antidepressants for Depression

NCT01109693 | Completed Phase 4 DMC

• 1 other identifier: sun-d
• Study Type: interventional
• Target: 2,011
• Locations: 1 country
• Sites: 2

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.

Conditions

Unipolar Major Depressive Episode

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Self-rated depression severity (BDI-II)

  9 weeks

• Global rating of side effects (FIBSER)

  9 weeks

Study Arms (3)

Continue sertraline

ACTIVE COMPARATOR

Continue sertraline at the dosage at 3 weeks

Drug: Sertraline

Augment with mirtazapine

ACTIVE COMPARATOR

Add mirtazapine to sertraline

Drug: Sertraline; Drug: Mirtazapine

Switch to mirtazapine

ACTIVE COMPARATOR

Stop sertraline and switch to mirtazapine

Drug: Mirtazapine

Interventions

Sertraline DRUG

Sertraline 50 mg/d or 100 mg/d for 6 more weeks

Augment with mirtazapine; Continue sertraline

Mirtazapine DRUG

Augment with or switch to mirtazapine 15-45 mg/d

Augment with mirtazapine; Switch to mirtazapine

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyoto University: lead
• National Center of Neurology and Psychiatry, Japan: collaborator

Study Sites (2)

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Kochi Medical School Hospital

Nangoku, Kochi, 783-8505, Japan

Location

Related Publications (4)

• 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.

  PMID: 29991347 DERIVED

• 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.

  PMID: 26466684 DERIVED

• 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.

  PMID: 22682213 DERIVED

• 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.

  PMID: 21569309 DERIVED

MeSH Terms

Interventions

Sertraline; Mirtazapine

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Toshiaki A Furukawa, MD, PhD

  Kyoto University Graduate School of Medicine / School of Public Health

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 23, 2010
• Study Start: December 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 3, 2016

Record last verified: 2016-09

Locations

JP (2)