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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004931
Receipt No. R000005869
Scientific Title An intervention study of optimizing algorism-based pharmacological treatment for schizophrenia
Date of disclosure of the study information 2011/01/22
Last modified on 2012/05/16

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Basic information
Public title An intervention study of optimizing algorism-based pharmacological treatment for schizophrenia
Acronym An intervention study of optimizing algorism-based pharmacological treatment for schizophrenia
Scientific Title An intervention study of optimizing algorism-based pharmacological treatment for schizophrenia
Scientific Title:Acronym An intervention study of optimizing algorism-based pharmacological treatment for schizophrenia
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy of algorism-based pharmacological treatment for schizophrenia by comparing the outcome measures (PANSS etc) between subjects with algorithm-guided treatment and those with treatment as usual in multi-center clinical trials.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Positive and Negative Syndrome Scale
Key secondary outcomes Clinical Global Impression Scale-Schizophrenia Version (CGI-SCH)
Global Assessment of Functioning (GAF)
Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS)
Targeted Inventory on Problem in Schizophrenia (TIP-Sz) and Assessment for Comprehensive Treatment of Schizophrenia (FACT-Sz)
Short-form 36 v2 Health Survey (SF-36v2)
Subjective Wellbeing under Neuroleptic Treatment Scale (SWN-J)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Algorithm-guided treatment group:
Treatment effectiveness is evaluated by the total score of monthly assessed PANSS. Responder is defined as more than 30% decrease from the baseline. PANSS score (Stages 1 and 2), and more than 20% decrease from the baseline (Stages 3 and 4). Non-responder is defined as less than 10% decrease from the baseline.
In case of treatment regarded as unfavorable (nonresponder), we proceed to the next stage.
Stage 1: one of the following atypical antipsychotics is used as monotherapy : aripiprazole, blonanserine, olanzapine, perospiron, quetiapine, risperidone. Treatment period is 8 weeks for first-episode and medication-naive patients with schizophrenia, and 12 weeks including 4 weeks switching period for patients with schizophrenia who already received antipsychotic medication.
Stage 2: one of the following atypical antipsychotics which was not used at Stage 1: aripiprazole, blonanserine, olanzapine, perospiron, quetiapine, risperidone.
Treatment period is the same as Stage1.
Stage 3: one of the following treatments should be selected.
1) Augmentation of the better antipsychotics at Stages 1 and 2 with either Sodium Valproate or Lithium.
2) Treatment by atypical antipsychotic not used at Stage 1 and 2.
3) Treatment by haloperidol (~12mg/day) or perphenazine (~48mg/day).
Treatment period is 16 weeks including 4 weeks switching period.
Stage 4: Give a medication not used through Stage 1 to 3, or antipsychotic combination therapy, or electroconvulsive therapy (ECT).
Interventions/Control_2 Control group:The subjects with Treatment as usual, not guided by treatment-algorism (TAU group).
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with schizophrenia diagnosed by DSM-IV.
2. Both in- and out-patients without remission will be recruited. Medication-naive or -free patients will be eligible. If the patients are treated by multiple antipsychotics (polypharmacy), the medication should be switched to one of the atypical antipsychotics (monopharmacy).
3. Patients are not in remission status, not resistant to antipsychotic therapy, and not having any severe complications.
4. Patients agree to participate in the study on a written informed consent form.
5. Patients should be able to receive examination and assessments for pharmaceutical therapy on designated date.
6. Patients with a total score of GAF ranging 11 to 90 and a score of severity in CGI-SCH ranging 3 to 6 are included. Moreover, we select patients with chlorpromazine-conversion dosage of 150mg to 2000mg/ day at baseline.
Key exclusion criteria 1. We exclude patients are in remission status, and showing mild or milder symptoms in all 8 subscales on PANSS.
Treatment-resistant cases: We exclude patients receive several antipsychotics (more than chlorpromazine-conversion dosage of 2000mg/ day during at least last 6 months, or taken more than 7 types of antipsychotics), but show a score less than 30 on FACT-SZ (definitely requiring hospitalization level).
2. Patients did not show any sufficient response to more than two kinds of atypical antipsychotics, or patients have intolerability to atypical antipsychotics so far.
3. Patients have severe underlying diseases, such as diabetes, substance dependence at present, serious physical disease, possibility of pregnancy, severe intellectual disorder, and organic brain disorder.
4. Patients show comorbid personality disorders diagnosed by DSM-IV.
5. Patients have high probability of attempting suicide.
6. Patients show an allergic reaction to a medication or have a history of the allergy.
7. Patients do not agree to participate in the study on a written informed consent form.
8. Patients are not able to receive examination and assessments for pharmaceutical therapy on designated date.
Target sample size 200

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

Public contact
Name of contact person
1st name
Middle name
Last name Motoichiro Kato
Organization Keio University
Division name Department of Neuropsychiatry, School of Medicine
Zip code
Address
TEL
Homepage URL
Email katomoto@sc.itc.keio.ac.jp

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

Funding Source
Organization Japanese Ministry of Health, Labor and Welfare (Health and Labor Sciences Research Grant for Research on
Psychiatric and Neurological Diseases and Mental Health H20-KOKORO-003)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Nippon Medical School
Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi
Kurumegaoka Hospital, Asai Hospital, Inogashira Hospital, Oizumi Hospital, Komagino Hospital
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 慶應義塾大学病院(東京都)
日本医科大学病院(東京都)
山梨大学付属病院(山梨県)
久留米ヶ丘病院(東京都)
浅井病院(千葉県)
井之頭病院(東京都)
大泉病院(東京都)
駒木野病院(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 22 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
2009 Year 08 Month 11 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 22 Day
Last modified on
2012 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005869

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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