UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009868
Receipt number R000011560
Scientific Title Prospective cohort study for changes of metabolic measures during antipsychotic treatments in patients with schizophrenia and bipolar disorder
Date of disclosure of the study information 2013/04/01
Last modified on 2018/11/01 08:30:37

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Basic information

Public title

Prospective cohort study for changes of metabolic measures during antipsychotic treatments in patients with schizophrenia and bipolar disorder

Acronym

Prospective cohort study for changes of metabolic measures during antipsychotic treatments in patients with schizophrenia and bipolar disorder (matSaB study)

Scientific Title

Prospective cohort study for changes of metabolic measures during antipsychotic treatments in patients with schizophrenia and bipolar disorder

Scientific Title:Acronym

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

1st name
Middle name
Last name Ichiro Kusumi

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Psychiatry

Zip code


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

1st name
Middle name
Last name Takashi Miyakoshi

Organization

Hokkaido University Hospital

Division name

Clinical Research and Medical Innovation Center

Zip code


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 or person

Institute

Department of Psychiatry, Hokkaido University Graduate School of Medicine

Institute

Department

Personal name



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)



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

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


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://dx.doi.org/10.1192/bjo.2018.56

Number of participants that the trial has enrolled


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.

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

Main results already published

Date of protocol fixation

2013 Year 03 Month 02 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011560


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name