UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004931
Receipt number 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 08:55:57

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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 or person

Institute

Department of Neuropsychiatry
Keio University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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