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Recruitment status Completed
Unique ID issued by UMIN UMIN000008667
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email jun49_86@yahoo.co.jp

Sponsor
Institute Inokashira Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010183


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