UMIN-CTR Clinical Trial

Public title

Acceptability and the course of major depression under newer antidepressant treatment
-One-year open-label, randomized, flexible dose study of either SSRI or SNRI in the treatment of major depression-

Acronym

Acceptability and the course of major depression under newer antidepressant treatment (ACCEPT study)

Scientific Title

Acceptability and the course of major depression under newer antidepressant treatment
-One-year open-label, randomized, flexible dose study of either SSRI or SNRI in the treatment of major depression-

Scientific Title:Acronym

Acceptability and the course of major depression under newer antidepressant treatment (ACCEPT study)

Region

Japan

Condition

Major depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the treatment continuation as well as safety and efficacy of newer antidepressants (escitalopram, duloxetine) during a one-year open-label clinical trial

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Treatment discontinuation and/or dropout rate for any reason at 8-week period

Key secondary outcomes

Treatment discontinuation rate (early/late phase)
Efficacy (symptom severity, response/remission rate)
Health outcome (QOL, functioning)
Safety (side effects, adverse events, ECG, laboratory data)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Flexible dose (10-20mg/day) of escitalopram will be first administered for 8 weeks (Step 1), and responders will continue escitalopram and non-responders will be switched to duloxetine in the next step, which will last 8 weeks (Step 2). Following Step 2, subjects will be followed up as long as possible until 52 weeks from the onset.

Interventions/Control_2

Flexible dose (20-60mg/day) of duloxetine will be first administered for 8 weeks (Step 1), and responders will continue duloxetine and non-responders will be switched to escitalopram in the next step, which will last 8 weeks (Step 2). Following Step 2, subjects will be followed up as long as possible until 52 weeks from the onset.

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)Fulfill criteria for major depressive disorder, as defined by DSM-IV criteria for single or recurrent without psychotic features, as determined by clinical assessment by treating psychiatrist and confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.).
2)Aged 20-75 years at screening.
3)Patients who have been treated with therapeutic dose of SSRI (sertraline, paroxetine or fluvoxamine) or SNRI (milnacipran) or NaSSA (mirtazapine) for at least 3 weeks.
4)Depression symptoms of at least moderate severity based on Clinical Global Impression of Severity (CGI-S) score >= 4.
5)Major depressive disorder is the primary diagnosis for the treatment and treating psychiatrist has judged study drug (i.e. escitalopram or duloxetine) to be appropriate for prescribing.
6)Competent and able to understand the meaning of the observation, evaluation and clinical examination in the judgment of the treating psychiatrist.
7)Competent and able to give their own informed consent.
8)Available on the phone for assessments.

Key exclusion criteria

1)Did not respond to 2 or more adequate antidepressants (each for at least 4 weeks with therapeutic dose ) during current depressive episode judged by the treating physician.
2)Comorbid psychiatric condition (DSM-IV axis 1) other than major depressive disorder that is considered as the primary diagnosis within 1 year of screening.
3)History of bipolar disorder, schizophrenia, or other psychotic disorder at screening by the treating physician.
4)History of substance abuse/dependence within 1 year of screening, except caffeine and nicotine.
5)Have an Axis 2 disorder that, judged by treating physician, would interfere with compliance with the study protocol.
6)Did not respond to escitalopram or duloxetine on maximum dose for at least 4 weeks during the past depressive episode.
7)Women who are currently pregnant or breastfeeding.
8)Patients who are judged by the treating physician to be at serious risk for harm to self or others.
9)Patients who are judged by the treating physician to have serious and/or unstable illness including problems in liver, kidney, respiratory system, hematological, endocrine system, or CNS, or traumatic brain injury.
10)Have a serious or unstable cardiovascular illness (including severe arrhythmia with bradycardia, prescribed with drugs known to cause QTc prolongation, congestive heart failure, hypokalemia), or clinically significant ECG abnormality (male: QTc>450ms, female: QTc>470ms).
11)Ongoing treatment with MAO inhibitors within 2 weeks of cessation of treatment.
12)Have an uncontrolled closed-angle glaucoma.
13)Ongoing treatment with Pimozide (Orap).
14)Patients who were diagnosed as Dementia using DSM-4-TR.
15)Patients who are judged by the treating physician to be inappropriate to participate in the study.

Target sample size

160

Name of lead principal investigator

1st name
Middle name
Last name	Kazuyuki Nakagome

Organization

National Center of Neurology and Psychiatry

Division name

Hospital

Zip code

Address

4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan

TEL

042-341-2711

Email

nakagome@ncnp.go.jp

Name of contact person

1st name
Middle name
Last name	Yuma Yokoi

Organization

National Center of Neurology and Psychiatry

Division name

Hospital First Division of Psychiatry

Zip code

Address

4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan

TEL

042-341-2711

Homepage URL

Email

yyokoi@ncnp.go.jp

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name

Organization

Mochida Pharmaceutical Co., Ltd.
Mitsubishi Tanabe Pharma Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

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

国立研究開発法人　国立精神・神経医療研究センター病院（東京都）
（National Center of Neurology and Psychiatry）

Date of disclosure of the study information

2013

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Partially published

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

Completed

Date of protocol fixation

2013

Year

10

Month

24

Day

Date of IRB

Anticipated trial start date

2013

Year

12

Month

01

Day

Last follow-up date

2018

Year

03

Month

31

Day

Date of closure to data entry

2018

Year

07

Month

31

Day

Date trial data considered complete

2018

Year

10

Month

31

Day

Date analysis concluded

2018

Year

12

Month

31

Day

Other related information

Registered date

2013

Year

11

Month

20

Day

Last modified on

2019

Year

02

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014458