UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006011 |
|---|---|
| Receipt number | 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 09:53:36 |
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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
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
Sponsor or person
Institute
Keio University, School of Medicine Department of Neuropsychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007115
