UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005527 |
|---|---|
| Receipt number | R000006552 |
| Scientific Title | Effects of atypical antipsychotics on cognitive functioning in schizophrenia |
| Date of disclosure of the study information | 2011/04/28 |
| Last modified on | 2015/11/02 16:40:52 |
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Basic information
Public title
Effects of atypical antipsychotics on cognitive functioning in schizophrenia
Acronym
Effects of atypical antipsychotics on cognitive functioning in schizophrenia
Scientific Title
Effects of atypical antipsychotics on cognitive functioning in schizophrenia
Scientific Title:Acronym
Effects of atypical antipsychotics on cognitive functioning in schizophrenia
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of atypical antipsychotics (Aripiprazol, Olanzapine, Risperipone, Quetiapine) on cognitive functioning in schizophrenia by comparing outcome measures (neuropsychological tests and functional brain imaging) before and after administration of atypical antipsychotics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Neuropsychological tests
-Rey-Osterrieth Complex Figure Test
-Rey Auditory Verbal Learning Test
-Trail Making Test
-Modified Stroop Test
-Word Fluency Test
-Digit Span
-Brown-Peterson Task
-Reflection Task
-Sense of agency Task
Neuroeconomics Related Task: performance and the brain activation in ventral striatum and prefrontal lobe during the task.
Key secondary outcomes
PANSS (Positive and Negative Syndrome Scale)
Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS)
Blood test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of atypical antipsychotics (aripiprazole, olanzapine, risperidone , quetiapine)
Interventions/Control_2
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. Patients with schizophrenia diagnosed by DSM-IV
2. Patients agree to participate in the study on a written informed consent form.
3. Patients should be able to receive examination and assessment on designated date.
4. Patients with a total score of GAF ranging 11 to 90 and a score of severity in CGI-SCH ranging 3 to 6 are included. Moreover, we select patients with chlorpromazine-conversion dosage of 150mg to 2000mg/ day at baseline.
Key exclusion criteria
1. We exclude a patient who is comatose.
2. Patients who are heavily influenced by central nervous system depressant such as barbiturate and anesthetics.
3. Patients who are on adrenergic medication
4. Patients with a history of sensitivity to atypical antipsychotics
5. Patients who are diabetic or patients with a history of diabetes
6. Patients who are pregnant or breast feeding, have possibility of pregnancy
7. Patients who cannot be administered orally
8. Patients who are on antiperkinson drug
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoichiro Kato |
Organization
Keio University
Division name
Department of Neuropsychiatry School of Medicine
Zip code
Address
Shinanomachi35 Shinjuku-ku Tokyo
TEL
03-5363-3829
katomoto@z7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaki Maeda |
Organization
Keio University
Division name
Department of Neuropsychiatry, School of Medicine
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
03-5363-3829
Homepage URL
takaki@xa3.so-net.ne.jp
Sponsor or person
Institute
Keio University School of Medicine
Department of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare science research funds subsidy
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | 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
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 28 | Day |
Last modified on
| 2015 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006552
