UMIN-CTR Clinical Trial

Basic information
Public title	A randomized open rabel study of the effects of aripiprazole in overweight and obstructive sleep apnea subjects with schizophrenia or schizoaffective disorder switched from other antipsychotic drugs.
Acronym	A randomized open rabel study of the effects of aripiprazole in overweight and obstructive sleep apnea subjects with schizophrenia or schizoaffective disorder switched from other antipsychotic drugs.
Scientific Title	A randomized open rabel study of the effects of aripiprazole in overweight and obstructive sleep apnea subjects with schizophrenia or schizoaffective disorder switched from other antipsychotic drugs.
Scientific Title:Acronym	A randomized open rabel study of the effects of aripiprazole in overweight and obstructive sleep apnea subjects with schizophrenia or schizoaffective disorder switched from other antipsychotic drugs.
Region	Japan

Condition
Condition	Schizophrenia Schizoaffective Disorder Obstructive Sleep Apnea Syndrome
Classification by specialty	Pneumology Psychiatry Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the effect of switching antipsychotic drug on severity of OSAS, body weight, and other metabolic abnormality among patients with schizophrenia or schizoaffective disorder.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Body Mass Index Apnea Hypopnea Index
Key secondary outcomes	The Brief Assessment of Cognition in Schizophrenia;BACS Positive and Negative Syndrome Scale;PANSS Activity assesed by actipraph

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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 Behavior,custom
Interventions/Control_1	Antipsychotic drugs used before trial will be partially or fully switched by aripiprazole.
Interventions/Control_2	Participants will be coached about exercise and nutrition for total 4 hours.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1.Participants diagnosed with schizophrenia or schizoaffective disorder. 2.Body weight gain is over 10kg compared with occurrence of mental disorder. 3.3% oxygen desaturation index evaluated with overnight pulseoxymetry in participants is over 5 times per hour.
Key exclusion criteria	1.3% oxygen desaturation index evaluated with overnight pulseoxymetry in participants is less than 5 times per hour.
Target sample size	54

Research contact person
Name of lead principal investigator	1st name Junichi Middle name Last name Murakami
Organization	Biwako Hospital
Division name	Department of psychiatry
Zip code	5200113
Address	Sakamoto 1-8-5, Otsu city, Shiga, JAPAN.
TEL	+81775782023
Email	murajun@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Junichi Middle name Last name Murakami
Organization	Biwako Hospital
Division name	Department of psychiatry
Zip code	52001113
Address	Sakamoto 1-8-5, Otsu city, Shiga, JAPAN.
TEL	+81775782023
Homepage URL
Email	murajun@belle.shiga-med.ac.jp

Sponsor
Institute	Biwako Hospital
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Biwako Hospital
Address	Sakamoto 1-8-5, Otsu city, Shiga, JAPAN.
Tel	+81775782023
Email	info@biwako.or.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	琵琶湖病院（滋賀県）

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 05 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	Terminated
Date of protocol fixation	2011 Year 03 Month 07 Day
Date of IRB	2011 Year 04 Month 01 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2012 Year 08 Month 01 Day
Date of closure to data entry	2012 Year 09 Month 01 Day
Date trial data considered complete	2012 Year 10 Month 01 Day
Date analysis concluded	2012 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date	2011 Year 03 Month 31 Day
Last modified on	2020 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006348