UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective cohort study for changes of metabolic measures during antipsychotic treatments in patients with schizophrenia and bipolar disorder
Title of the study (Brief title)	Prospective cohort study for changes of metabolic measures during antipsychotic treatments in patients with schizophrenia and bipolar disorder (matSaB study)
Region	Japan

Condition
Condition	Schizophrenia, Bipolar disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To monitor the changes of metabolic measures using the Japanese blood glucose monitoring guidance during the antipsychotic treatments in patients with schizophrenia or bipolar disorder
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in the frequency of subtypes based on monitoring guidance during one-year follow-up and difference in them among antipsychotics
Key secondary outcomes	Relationship between metabolic deterioration and clinical measures, and difference in them among antipsychotics

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	-Patients with schizophrenia or bipolar disorder who will newly receive indicated antipsychotics -Patients who have the records of medical history in past 1 year -Patients whom written informed consent is obtained
Key exclusion criteria	-Patients who are participating in an investigational drug study -Patients who have or had diabetes
Target sample size	1200

Research contact person
Name of lead principal investigator	Ichiro Kusumi
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Psychiatry
Address	North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL	011-706-5160
Email	ikusumi@med.hokudai.ac.jp

Public contact
Name of contact person	Takashi Miyakoshi
Organization	Hokkaido University Hospital
Division name	Clinical Research and Medical Innovation Center
Address	North 14, West 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
TEL	011-706-7735
Homepage URL
Email	matSaB@pop.med.hokudai.ac.jp

Sponsor
Institute	Department of Psychiatry, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Clinical Trials Core Hospitals
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

北海道大学病院（北海道）、国立精神・神経医療研究センター（東京都）、東京女子医科大学（東京都）、千葉大学（千葉県）、聖マリアンナ医科大学（神奈川県）、順天堂大学医学部附属練馬病院（東京都）、豊島病院（東京都）、杏林大学（東京都）、奈良県立医科大学（奈良県）、関西医科大学（大阪府）、徳島大学（徳島県）、愛媛大学（愛媛県）、産業医科大学（福岡県）、国立病院機構肥前精神医療センター（佐賀県）、岡山県精神医療センター（岡山県）、慈圭病院（岡山県）、明星病院（熊本県）、青森県立中央病院（青森県）、三重大学（三重県）、北里大学（神奈川県）、市立札幌病院精神医療センター（北海道）、細木ユニティ病院（高知県）、桶狭間病院藤田こころケアセンター（愛知県）、札幌花園病院（北海道）、函館渡辺病院（北海道）、札幌鈴木病院（北海道）、八雲総合病院（北海道）、倶知安厚生病院（北海道）、恵愛病院（北海道）、苫小牧緑ヶ丘病院（北海道）、北海道立向陽ヶ丘病院（北海道）、市立稚内病院（北海道）、市立室蘭総合病院（北海道）、小樽市立脳・循環器・こころの医療センター（北海道）、市立釧路総合病院（北海道）、手稲病院（北海道）、石金病院（北海道）、本田記念病院（北海道）、林下病院（北海道）、飯田病院（長野県）、国立病院機構帯広病院（北海道）、札幌こころの森クリニック（北海道）、西病院（北海道）、岡本病院（北海道）、岡本メンタルクリニック（北海道）、岡本中央メンタルクリニック（北海道）、牧病院（北海道）、大谷地病院（北海道）

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 03 Month 02 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 06 Month 30 Day
Date trial data considered complete	2016 Year 07 Month 21 Day
Date analysis concluded	2017 Year 03 Month 27 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://dx.doi.org/10.1192/bjo.2018.56
Results	High baseline serum triglycerides and coexisting hypertension significantly predicted hyperglycemic progression in schizophrenia/ bipolar disorder patients treated with antipsychotics. Irrespective of the antipsychotic used, comprehensive longitudinal monitoring is essential in regular clinical practice.
Other related information	Prospective study Data will be consecutively collected Examine relationship between metabolic deterioration and metabolic deterioration

Management information
Registered date	2013 Year 01 Month 25 Day
Last modified on	2018 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011560