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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006011
Receipt No. R000007115
Scientific Title Dopamine D2 Receptor Blockade by Antipsychotics and Maintenance of Remission in Schizophrenia
Date of disclosure of the study information 2011/08/01
Last modified on 2014/01/20

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Basic information
Public title Dopamine D2 Receptor Blockade by Antipsychotics and Maintenance of Remission in Schizophrenia
Acronym D2 Receptor Blockade and Remission in Schizophrenia
Scientific Title Dopamine D2 Receptor Blockade by Antipsychotics and Maintenance of Remission in Schizophrenia
Scientific Title:Acronym D2 Receptor Blockade and Remission in Schizophrenia
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to examine the relationship between the outcome and the estimated dopamine D2 receptor occupancy using plasma levels of antipsychotics and population pharmacokinetic techniques and elucidate appropriate antipsychotic treatment in terms of the quantity and quality of dopamine D2 receptor occupancy levels in remitted patients with schizophrenia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Positive and Negative Syndrome Scale (PANSS), Simpson-Angus Scale (SAS), Barnes Akathisia Rating Scale (BAS), Abnormal Involuntary Movement Scale (AIMS), Japanese version of the Calgary Depression Scale for Schizophrenics (JCDSS), Subjective Well-being under Neuroleptic drug treatment Short form, Japanese version (SWNS-J)
Key secondary outcomes Clinical Global Impression–Schizophrenia (CGI-SCH), Global Assessment of Functioning (GAF)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 continuous D2 blockade of >65%. Subjects will be treated with an individually prepared regimen and observed for one year.
Interventions/Control_2 Intermittent D2 blockade of >65%. Subjects will be treated with an individually prepared regimen and observed for one year.
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) DSM-IV diagnosis of schizophrenia or schizoaffective disorder
(2) Having received a stable dose of risperidone or olanzapine for previous 3 months
Key exclusion criteria (1) Receiving another antipsychotic drug
(2) History of treatment with long-acting risperidone within 6 months
(3) Past history of vagus nerve reflection with a blood test
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Uchida
Organization Keio University, School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University, School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
Homepage URL
Email

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

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2011 Year 08 Month 01 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 07 Month 11 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 20 Day
Last modified on
2014 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007115

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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