Strategic Use of New Generation Antidepressants for Depression

Conditions

Unipolar Major Depressive Episode

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.

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.

2018-07-1141 citations

10.1186/s12916-018-1096-5

Strategic use of new generation antidepressants for depression: SUN(^_^) D protocol update and statistical analysis plan.

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.

2015-10-145 citations

10.1186/s13063-015-0985-6

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.

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.

2012-06-087 citations

10.1186/1745-6215-13-80

Strategic use of new generation antidepressants for depression: SUN(^_^)D study protocol.

Furukawa TA, Akechi T, Shimodera S, Yamada M, Miki K, Watanabe N, Inagaki M, Yonemoto N.

2011-05-1121 citations

10.1186/1745-6215-12-116

Interventions

DRUGSertraline

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

DRUGMirtazapine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 75 Years

Healthy volunteers

No

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Self-rated depression severity (BDI-II)	9 weeks	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)	9 weeks	FIBSER stands for Frequency, Intensity and Burden of Side Effects Rating, which is an observer-rated global rating of side effects.

Countries

Japan

Outcome results

None listed