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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012367
Receipt No. R000014458
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-
Date of disclosure of the study information 2013/12/01
Last modified on 2019/02/13

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Basic information
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
Condition Major depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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)

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Mochida Pharmaceutical Co., Ltd.
Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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)

Other administrative information
Date of disclosure of the study information
2013 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
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

Progress
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
Other related information

Management information
Registered date
2013 Year 11 Month 20 Day
Last modified on
2019 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014458

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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