UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005355 |
|---|---|
| Receipt number | 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 | 2020/10/31 10:25:37 |
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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
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
murajun@belle.shiga-med.ac.jp
Sponsor or person
Institute
Biwako Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006348
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| Registered date | File name |
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