UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008667 |
|---|---|
| Receipt number | R000010183 |
| Scientific Title | Antipsychotic dose increase or stay in non-responders with schizophrenia: A double-blind randomized controlled trial |
| Date of disclosure of the study information | 2012/09/13 |
| Last modified on | 2015/05/10 19:07:58 |
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Basic information
Public title
Antipsychotic dose increase or stay in non-responders with schizophrenia: A double-blind randomized controlled trial
Acronym
Antipsychotic dose increase or stay in non-responders with schizophrenia
Scientific Title
Antipsychotic dose increase or stay in non-responders with schizophrenia: A double-blind randomized controlled trial
Scientific Title:Acronym
Antipsychotic dose increase or stay in non-responders with schizophrenia
Region
| Japan |
Condition
Condition
schizophrenia, schizoaffective disorder, persistent delusional disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to compare 4-week outcomes between increasing the dose of ongoing antipsychotic drugs versus maintaining the dose in patients with schizophrenia who present clinically significant psychopathology.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Completion rates of treatment
Key secondary outcomes
Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Severity of Illness (CGI-S), Clinical Global Impression-Global Improvement (CGI-GI), Global Assessment of Functioning (GAF), Functional Assessment for Comprehensive Treatment of Schizophrenia (FACT-Sz), Targeted Inventory on Problems in Schizophrenia (TIP-Sz), Simpson-Angus Scale (SAS), Barnes Akathisia Rating Scale (BAS), Abnormal Involuntary Movement Scale (AIMS), and plasma concentrations of olanzapine or risperidone at week 4 and 8
Prediction of the group allocation by subjects and assessors at week 4 immediately before it is revealed
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
(A) Dose increment to the maximum dose of the ongoing antipsychotic drug
(1) Phase-I (4 weeks)
olanzapine 20 mg/d or risperidone 6 mg/d
Other prescribed psychotropic drugs will be kept constant or could be only reduced as clinically appropriate. However, when clinically indicated, lorazepam, zolpidem, and biperiden are allowed to add on the regimen.
Interventions/Control_2
(B) Stay on the same dose
(1) Phase-I (4 weeks)
olanzapine 10 mg/d or risperidone 3 mg/d
Other prescribed psychotropic drugs will be kept constant or could be only reduced as clinically appropriate. However, when clinically indicated, lorazepam, zolpidem, and biperiden are allowed to add on the regimen.
(2) Phase-II (4 weeks)
olanzapine 20 mg/d or risperidone 6 mg/d
After subjects complete the phase-I, their assigned group will be revealed. Subjects who were assigned to the dose continuation group (Group B) in the Phase-I and failed to experience a >= 25% decrease in the PANSS will be included in Phase-II. The dose of olanzapine or risperidone will be increased to the maximum dose (i.e., olanzapine 20 mg/d; risperidone 6 mg/d) in an open-label fashion.
Also in this phase, other prescribed psychotropic drugs will be kept constant or could be only reduced as clinically appropriate. However, when clinically indicated, lorazepam, zolpidem, and biperiden are allowed to add on the regimen.
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) Diagnosis of schizophrenia, schizoaffective disorder, or persistent delusional disorder according to the International Classification of Diseases, 10th Revision (ICD-10)
(2) Having been treated with olanzapine 10 mg/d or risperidone 3 mg/d for >= 4 weeks
(3) >= 60 on the total score of the PANSS
(4) <= 70 on the GAF
(5) >= 3 on the CGI-S
(6) Being >= 20 years old and competent to contact
Key exclusion criteria
(1) Concomitant use of another antipsychotic drug within the last 4 weeks
(2) Past history of non-response or intolerability to the maximum dose of the current antipsychotic drug (i.e., olanzapine 20 mg/d; risperidone 6 mg/d)
(3) Active suicidal ideations or past suicide attempts
(4) Severe physical disease
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Sakurai |
Organization
Inokashira Hospital
Division name
Psychiatry
Zip code
Address
14-1 4-cyoume, Kami-renjaku, Mitaka-shi, Tokyo 181-8531, Japan
TEL
0422-44-5331
jun49_86@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Sakurai |
Organization
Inokashira Hospital
Division name
Psychiatry
Zip code
Address
14-1 4-cyoume, Kami-renjaku, Mitaka-shi, Tokyo 181-8531, Japan
TEL
0422-44-5331
Homepage URL
jun49_86@yahoo.co.jp
Sponsor or person
Institute
Inokashira Hospital
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
井之頭病院（東京都）、南飯能病院（埼玉県）、大泉病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 13 | 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
| 2012 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 10 | Day |
Last modified on
| 2015 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010183
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