UMIN-CTR Clinical Trial

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
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