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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034779
Receipt No. R000039606
Official scientific title of the study Adherence to Antipsychotics in Treatment-Resistant Schizophrenia: A Prospective Observational Study
Date of disclosure of the study information 2018/11/06
Last modified on 2018/11/19

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Basic information
Official scientific title of the study Adherence to Antipsychotics in Treatment-Resistant Schizophrenia: A Prospective Observational Study
Title of the study (Brief title) Adherence to Antipsychotics in Treatment-Resistant Schizophrenia: A Prospective Observational Study
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify apparent treatment-resistant schizophrenia (TRS) by measuring medication adherence with Medication Event Monitoring System (MEMS)
Basic objectives2 Others
Basic objectives -Others To examine the relationship between medication adherence and symptom severity in TRS
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Medication adherence measured by MEMS (at 12 weeks)
Key secondary outcomes (1) Medication adherence measured by pill counts or Brief Adherence Rating Scale (BARS)
(2) Psychopathology measured by rating scales

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients with treatment-resistant schizophrenia receiving only oral antipsychotics
Key exclusion criteria None
Target sample size 120

Research contact person
Name of lead principal investigator Hiroyoshi Takeuchi
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, JAPAN
TEL 03-3353-1211
Email hirotak@dk9.so-net.ne.jp

Public contact
Name of contact person Hiroyoshi Takeuchi
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, JAPAN
TEL 03-3353-1211
Homepage URL
Email hirotak@dk9.so-net.ne.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization SENSHIN Medical Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

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 山梨県立北病院(山梨県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 06 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 19 Day
Anticipated trial start date
2018 Year 11 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information This study is a prospective observational study.

Management information
Registered date
2018 Year 11 Month 05 Day
Last modified on
2018 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039606

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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