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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005355
Receipt No. R000006348
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.
Date of disclosure of the study information 2011/04/05
Last modified on 2020/10/26

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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 Enrolling by invitation
Date of protocol fixation
2011 Year 03 Month 07 Day
Date of IRB
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 26 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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