UMIN-ICDS Clinical Trial

Public title

Strategic Use of New generation antidepressants for Depression

Acronym

SUN(^_^)D

Scientific Title

Strategic Use of New generation antidepressants for Depression

Scientific Title:Acronym

SUN(^_^)D

Region

Japan

Condition

Major depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

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.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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

Key secondary outcomes

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Continue sertraline

Interventions/Control_2

Augment sertraline with mirtazapine

Interventions/Control_3

Switch to mirtazapine

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

25

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key 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

Key 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

Target sample size

2000

Name of lead principal investigator

1st name
Middle name
Last name	Toshi A. Furukawa

Organization

Kyoto University Graduate School of Medicine / School of Public Health

Division name

Department of Health Promotion and Human Behavior

Zip code

Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto

TEL

075-753-9491

Email

furukawa@kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Mitsuhiko Yamada

Organization

National Center of Neurology and Psychiatry

Division name

Department of Neuropsychopharmacology

Zip code

Address

Higashi-cho 4-1, Kodaira, Tokyo

TEL

042-346-9519

Homepage URL

Email

mitsu@ncnp.go.jp

Institute

Steering Committee of SUN(^_^)D

Institute

Department

Personal name

Organization

Japan Foundation for Neuroscience and Mental Health

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

NCT01109693

Org. issuing International ID_1

clinicaltrial.gov

Study ID_2

JapicCTI-101199

Org. issuing International ID_2

Japic

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

11

Month

01

Day

URL releasing protocol

https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-12-116

Publication of results

Published

URL related to results and publications

https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-018-1096-5

Number of participants that the trial has enrolled

Results

Between December 2010 and March 2015, we recruited 2,011 participants with hitherto untreated major depression at 48 clinics in Japan. In Step 1, 970 participants were allocated to the 50 mg/day and 1,041 to the 100 mg/day arms; 1,927 (95.8%) provided primary outcomes. There was no statistically significant difference in the adjusted PHQ-9 score at week 9 between the 50 mg/day arm and the 100 mg/day arm (0.25 points 95% CI, -0.58 to 1.07, P=0.55). Other outcomes proved similar in the two groups.
In Step 2, 1,646 participants not remitted by week 3 were randomised to continue sertraline (n=551), to add mirtazapine (n=537), or to switch to mirtazapine (n=558): 1,613 (98.0%) provided primary outcomes. At week 9, adding mirtazapine achieved a reduction in PHQ-9 scores of 0.99 points (0.43 to 1.55, P=0.0012); switching achieved a reduction of 1.01 points (0.46 to 1.56, P=0.0012), both relative to continuing sertraline. Combination increased the percentage of remission by 12.4% (6.1% to 19.0%) and switching by 8.4% (2.5% to 14.8%). There were no differences in adverse effects.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2010

Year

04

Month

22

Day

Date of IRB

2010

Year

08

Month

30

Day

Anticipated trial start date

2010

Year

12

Month

01

Day

Last follow-up date

2015

Year

03

Month

31

Day

Date of closure to data entry

2015

Year

03

Month

31

Day

Date trial data considered complete

2015

Year

03

Month

31

Day

Date analysis concluded

2018

Year

06

Month

06

Day

Other related information

Registered date

2017

Year

11

Month

01

Day

Last modified on

2024

Year

03

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034028