UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003531 |
|---|---|
| Receipt number | R000004258 |
| Scientific Title | A randomized controlled trial of antipsychotic combination in acute-phase schizophrenia |
| Date of disclosure of the study information | 2010/05/31 |
| Last modified on | 2015/04/03 12:45:06 |
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Basic information
Public title
A randomized controlled trial of antipsychotic combination in acute-phase schizophrenia
Acronym
A randomized controlled trial of antipsychotic combination in schizophrenia
Scientific Title
A randomized controlled trial of antipsychotic combination in acute-phase schizophrenia
Scientific Title:Acronym
A randomized controlled trial of antipsychotic combination in schizophrenia
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our question is whether antipsychotic combination is effective for early non-responder to an antipsychotic in acute-phase schizophrenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
50% and more improvement in the PANSS total score
Key secondary outcomes
PANSS, CGI, GAF
treatment discontinuation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Early non-responder to risperidone(6mg or less) will be assigned to combination with olanzapine(20mg or less). Follow-up period is 8 weeks.
Interventions/Control_2
Early non-responder to risperidone(6mg or less) will be assigned to risperidone monotherapy (12mg or less). Follow-up period is 8 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
newly admitted as emergency cases, and met criteria of the DSM-IV for schizophrenia, schizophreniform disorder, or schizoaffective disorder
Key exclusion criteria
1) obvious complications such as liver dysfunction, renal dysfunction, heart failure, and respiratory failure
2) diabetes mellitus
3) Patients who were pregnant or who want to become pregnant
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kotaro Hatta |
Organization
Juntendo University Nerima Hospital
Division name
Department of Psychiatry
Zip code
Address
3-1-10 Takanodai, Nerima-ku, Tokyo 177-8521, Japan
TEL
03-5923-3111
khatta@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Hatta |
Organization
Juntendo University Nerima Hospital
Division name
Department of Psychiatry
Zip code
Address
3-1-10 Takanodai, Nerima-ku, Tokyo 177-8521, Japan
TEL
03-5923-3111
Homepage URL
khatta@juntendo.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Intramural Research Grant (20B-8) for Neurological and Psychiatric Disorders of NCNP (National Center of Neurology and Psychiatry)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
さわ病院（大阪府）、群馬県立精神医療センター（群馬県）、埼玉県立精神医療センター（埼玉県）、土佐病院（高知県）、兵庫県立光風病院（兵庫県）、静岡こころの医療センター（静岡県）、千葉県精神科医療センター（千葉県）、豊島病院（東京都）、茨城県立友部病院（茨城県）、三重県立精神科医療センター（三重県）、福井県立病院こころの医療セン
ター（福井県）、肥前精神医療センター（佐賀県）、東京武蔵野病院（東京都）、国立国際医療センター国府台病院（千葉県）、栃木県立岡本台病院（栃木県）、旭川圭泉会病院（北海道）、佐藤病院（山形県）、東京都立松沢病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Seventy-eight patients completed 2 weeks of treatment, and divided into early responders to risperidone (n=52), and early non-responders to risperidone (the RIS+OLZ group, n=13; the RIS+RIS group, n=13). At 10 weeks, there was no significant difference in the achievement of >=50% response between the two early non-responder groups (23% vs. 23%). Remarkably, difference in time to treatment discontinuation for any cause between early responders to risperidone and the RIS+OLZ group was not found (8.6 weeks [95%CI: 7.9-9.3] vs. 7.9 weeks [6.3-9.5], P=0.37) although that was significantly longer in early responders to risperidone than in the RIS+RIS group (8.6 weeks [7.9-9.3] vs. 6.8 weeks [5.2-8.4], P=0.018).
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
Main results already published
Date of protocol fixation
| 2010 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 24 | Day |
Last modified on
| 2015 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004258
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| Registered date | File name |
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| Registered date | File name |
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