UMIN-CTR Clinical Trial

Public title

Augmentation of omega-3 fatty acid with antidepressants for major depressive disorder: a double-blind, randomized controlled trial

Acronym

SAKANA for relieving depression in patients taking escitalopram (Sardine study)

Scientific Title

Augmentation of omega-3 fatty acid with antidepressants for major depressive disorder: a double-blind, randomized controlled trial

Scientific Title:Acronym

SAKANA for relieving depression in patients taking escitalopram (Sardine study)

Region

Japan

Condition

major depressive disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to examine the efficacy of augmentation of omega-3 fatty acid with escitalopram in patients with major depressive disorder.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

Hamilton Raing Scale for Depression[Time frame: 12 weeks]

Key secondary outcomes

MADRS
SDS
BDI
QIDS-J
CGI-S
RS-14
Serum BDNF, proBDNF, MMP-9, fatty acid level
Plasma IL-6

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Omega-3 Polyunsaturated fatty acid

Interventions/Control_2

placebo

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. The subject did not receive any antidepressant drugs(≥4 weeks at minimal effective dose) for major depression
2. Total HDRS-17 score ≥17
3. The major depressive episode is the focus of the treatment and the treating physician has judged escitalopram to be its appropriate 1st line drug
4. A native Japanese speaker
5. The participant is able to understand and sign written informed consent.

Key exclusion criteria

1. History of schizophrenia, schizoaffective disorder or bipolar disorder (DSM-IV) as judged by treating physician.
2. Current dementia, borderline personality disorder, eating disorder or substance dependence (DSM-IV) as judged by treating physician.
3. Imminent high risk of suicide as judged by treating physician.
4. Use of antipsychotic drugs and antidepressant drugs within 1 week of the visit
5. Physical diseases which may contraindicate treatment with escitalopram.
6. Currently pregnant or breast-feeding women
7. Regular consumption of polyunsaturated fatty acid supplements within the last 3 months
8. A habit of eating fish >= 4 times per week, to ensure comparability to patients studied in Western countries.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Wakako Nakano

Organization

University of Occupational and Environmental Health

Division name

Department of Psychiatry

Zip code

Address

1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka 807-8555, Japan

TEL

093-691-7253

Email

wakako-u@med.uoeh-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Wakako Nakano

Organization

University of Occupational and Environmental Health

Division name

Department of Psychiatry

Zip code

Address

1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka 807-8555, Japan

TEL

093-691-7253

Homepage URL

Email

wakako-u@med.uoeh-u.ac.jp

Institute

University of Occupational and Environmental Health

Institute

Department

Personal name

Organization

University of Occupational and Environmental Health

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

National Center of Neurology and Psychiatry
University of Toyama
Tohoku Medical Megabank Organization, Tohoku University
Tohoku Fukushi University
Hakatachikushiguchi cocoro clinic

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

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

Open public recruiting

Date of protocol fixation

2014

Year

03

Month

25

Day

Date of IRB

Anticipated trial start date

2014

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

03

Month

27

Day

Last modified on

2014

Year

04

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015776