UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005527
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email takaki@xa3.so-net.ne.jp

Sponsor
Institute Keio University School of Medicine
Department of Neuropsychiatry
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006552

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.