UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037946
Receipt number R000041477
Scientific Title Impact of switching to single dosing regimen of antipsychotics on medication adherence in schizophrenia: A randomized controlled trial
Date of disclosure of the study information 2019/09/06
Last modified on 2024/03/10 22:41:33

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Basic information

Public title

Impact of switching to single dosing regimen of antipsychotics on medication adherence in schizophrenia: A randomized controlled trial

Acronym

Impact of switching to single dosing regimen of antipsychotics on medication adherence in schizophrenia: A randomized controlled trial

Scientific Title

Impact of switching to single dosing regimen of antipsychotics on medication adherence in schizophrenia: A randomized controlled trial

Scientific Title:Acronym

Impact of switching to single dosing regimen of antipsychotics on medication adherence in schizophrenia: A randomized controlled trial

Region

Japan


Condition

Condition

Schizophrenia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To improve medication adherence in schizophrenia

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Medication adherence at 12 weeks after intervention

Key secondary outcomes

Positive and Negative Syndrome Scale (PANSS); Brief Evaluation of Psychosis Symptom Domains (BE-PSD); Clinical Global Impression - Global Severity (CGI-S); Brief Assessment of Cognition in Schizophrenia (BACS); Personal and Social Performance Scale (PSP); Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS); UKU Side Effect Rating Scale (UKU-SERS); Subjective well-being under neuroleptic drug treatment short form (SWNS); Perceived Deficits Questionnaire (PDQ); Visual Analogue Scale for Distress Associated with Symptoms (VAS-DAS); blood sampling for general test, plasma assay at start and 12 weeks after intervention


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 not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Switching multiple daily dosing regimen of antipsychotics to single dosing regimen

Interventions/Control_2

Continuing multiple daily dosing regimen of antipsychotics

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

(1) Japanese outpatient without admission for recent at least 3 months
(2) Being diagnosed with schizophrenia according to ICD-10
(3) Receiving oral antipsychotics twice or more a day without any change in type, dose, or dosing regimen of antipsychotics for at least 3 months, and not receiving long-acting injectable antipsychotics
(4) Not lower than 20 years old
(5) Being capable to provide informed consent

Key exclusion criteria

(1) Having serious medical conditions
(2) Having a history of mental and behavioral disorders due to psychoactive substance use
(3) Being pregnant or lactating
(4) Being incapable to understand Japanese language
(5) Having a history of blood sampling-induced vasovagal reaction
(6) Being judged as inappropriate by investigators

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hiroyoshi
Middle name
Last name Takeuchi

Organization

Yamanashi Prefectural Kita Hospital

Division name

Department of psychiatry

Zip code

407-0046

Address

3314-13 Minamiwari, Kamijyo, Asahi-machi, Nirasaki-shi, Yamanashi, 407-0046, Japan

TEL

0551-22-1621

Email

hirotak@dk9.so-net.ne.jp


Public contact

Name of contact person

1st name Hodaka
Middle name
Last name Yaegashi

Organization

Yamanashi Prefectural Kita Hospital

Division name

Department of psychiatry

Zip code

407-0046

Address

3314-13 Minamiwari, Kamijyo, Asahi-machi, Nirasaki-shi, Yamanashi, 407-0046, Japan

TEL

0551-22-1621

Homepage URL


Email

h.yaemon@hotmail.co.jp


Sponsor or person

Institute

Yamanashi Prefectural Kita Hospital

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Yamanashi Prefectural Central Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB of Yamanashi Prefectural Kita Hospital

Address

3314-13 Minamiwari, Kamijyo, Asahi-machi, Nirasaki-shi, Yamanashi, 407-0046, Japan

Tel

0551-22-1621

Email

m-saegusa@ych.pref.yamanashi.jp


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


Other administrative information

Date of disclosure of the study information

2019 Year 09 Month 06 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Suspended

Date of protocol fixation

2019 Year 08 Month 02 Day

Date of IRB

2019 Year 08 Month 19 Day

Anticipated trial start date

2019 Year 09 Month 06 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 09 Month 06 Day

Last modified on

2024 Year 03 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041477


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name