UMIN-CTR Clinical Trial

Basic information
Public title	Model-Guided Antipsychotic Dose Reduction in Schizophrenia: A Single-Blind Randomized Controlled Trial
Acronym	Model-Guided Antipsychotic Dose Reduction in Schizophrenia: A Single-Blind Randomized Controlled Trial
Scientific Title	Model-Guided Antipsychotic Dose Reduction in Schizophrenia: A Single-Blind Randomized Controlled Trial
Scientific Title:Acronym	Model-Guided Antipsychotic Dose Reduction in Schizophrenia: A Single-Blind Randomized Controlled Trial
Region	Japan

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

Objectives
Narrative objectives1	The objective of this study is to test the effectiveness of the model-guided antipsychotic dose reduction in clinically stable patients with schizophrenia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of successful completers
Key secondary outcomes	Positive and Negative Syndrome Scale

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	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The dose will be reduced to an individually estimated target dose that correspond to 65% dopamine D2 receptor blockade at trough.
Interventions/Control_2	The dose will be maintained throughout the study period.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) DSM-IV and DSM5 diagnosis of schizophrenia (2) Having received a stable dose of risperidone or olanzapine for the previous 3 months (3) 18 years-old or older and being capable of providing informed consent
Key exclusion criteria	(1) Concomitant use of antipsychotic drugs other than quetiapine at 50 mg or less or its chlorpromazine equivalent at bedtime (2) History of treatment with long-acting risperidone within 6 months (3) Active suicidal ideations or past suicide attempts (4) Presence of severe physical condition, mental retardation, or active substance abuse
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroyuki Uchida
Organization	Minamihanno Hospital
Division name	Department of Psychiatry
Zip code
Address	415 Yaoroshi, Hanno, Saitama
TEL	042-972-7111
Email	hiroyuki.uchida.hu@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Hiroyuki Uchida
Organization	Minamihanno Hospital
Division name	Department of Psychiatry
Zip code
Address	415 Yaoroshi, Hanno, Saitama
TEL	042-972-7111
Homepage URL
Email	hiroyuki.uchida.hu@gmail.com

Sponsor
Institute	Minamihanno Hospital
Institute
Department

Funding Source
Organization	Takeda Science Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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	南飯能病院（埼玉県）、恩方病院（東京都）、大泉病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 28 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	Completed
Date of protocol fixation	2014 Year 05 Month 10 Day
Date of IRB	2014 Year 08 Month 08 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date	2018 Year 06 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date	2014 Year 08 Month 28 Day
Last modified on	2020 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017430