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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007942
Receipt No. R000009273
Scientific Title Long-term study on discontinuation rate, resolution/remission, and improvement in social functioning rate associated with atypical antipsychotic medications in patients with schizophrenia
Date of disclosure of the study information 2012/05/14
Last modified on 2018/12/07

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Basic information
Public title Long-term study on discontinuation rate, resolution/remission, and improvement in social functioning rate associated with atypical antipsychotic medications in patients with schizophrenia
Acronym Japan Useful Medication Program for Schzophrenia[JUMPs]
Scientific Title Long-term study on discontinuation rate, resolution/remission, and improvement in social functioning rate associated with atypical antipsychotic medications in patients with schizophrenia
Scientific Title:Acronym Japan Useful Medication Program for Schzophrenia[JUMPs]
Region
Japan

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

Objectives
Narrative objectives1 The objective of this multi-center, open-label, randomized, parallel-group comparative study is to investigate the discontinuation rate, resolution/remission, and improvement in social functioning rate associated with the long-term use of atypical antipsychotic medications (aripiprazole, blonanserin, and paliperidone) in patients with schizophrenia.
Basic objectives2 Others
Basic objectives -Others Discontinuation rate
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes - Discontinuation rate
Key secondary outcomes - Resolution/remission
- Social functioning rate (change in PSP and EQ-5D sores)
- Improvement and worsening/recurrence of psychiatric symptoms
- Safety (adverse events, DIEPSS)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Aripiprazole group
(maximum of 104 weeks)
Interventions/Control_2 Blonanserin group
(maximum of 104 weeks)
Interventions/Control_3 Paliperidone group
(maximum of 104 weeks)
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 The subjects will be patients meeting all of the following criteria.
- Out-patients 20 years of age or older at the time informed consent is obtained
- Patients with schizophrenia meeting the DSM-IV-TR diagnostic criteria
- Patients who require treatment with an antipsychotic medication, or patients who need to switch their current antipsychotic medication because the treatment is ineffective or poorly tolerated, or for some other reason
- Patients who personally give written informed consent to participate in the study
Key exclusion criteria Patients meeting any of the following criteria will be excluded from the study.
- Patients with a prior history of hypersensitivity to components of the study drugs or to risperidone
- Patients who are strongly under the influence of central nervous depressants such as barbiturate derivatives
- Patients on adrenalin treatment
- Patients on azole antimycotics (except for topicals) or HIV protease inhibitors
- Patients with moderate to severe renal impairment (creatinine clearance < 50 mL/min at eligibility screening)
- Patients with poorly controlled diabetes mellitus (HbA1c (NGSP level) >= 8.4% at eligibility screening)
- Patients with symptoms that remain severe despite adequate treatment, and patients for whom the use of clozapine is contraindicated
- Patients with other mental conditions
- Patients with Parkinson's disease
- Patients with malignant syndromes or similar symptoms, and patients with water intoxication
- Patients who are physically exhausted from dehydration, poor nutrition, or the like
- Patients with malignancies who require treatment
- Patients with a history of alcohol or drug abuse
- Women who are or may be pregnant, breastfeeding women, or women who want to become pregnant while participating in the study
- Patients who are highly likely to attempt suicide (patients with a CGI-SS (Clinical Global Impression Scale for Severity of Suicidality) >= 4)
- Patients who investigators judge to be unsuitable as subjects
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Ishigooka,MD.,Ph.D.
Organization Tokyo Women's Medical University
Division name Department of Psychiatry
Zip code
Address 8-1 Kawada-cho,Shinjuku-ku,Tokyo
TEL 03-3353-8112
Email jump@mebix.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name JUMPs Study Executive Office Support Center (Mebix, Inc.)
Organization JUMPs Study Executive Office Support Center (Mebix, Inc.)
Division name Research Promotion Group
Zip code
Address 1-11-44 Akasaka, Minato-ku, Tokyo
TEL 03-4362-4504
Homepage URL
Email jump@mebix.co.jp

Sponsor
Institute JUMPs Research Group
Institute
Department

Funding Source
Organization The Waksman Foundation of Japan INC.
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 14 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 No longer recruiting
Date of protocol fixation
2012 Year 04 Month 23 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2016 Year 02 Month 28 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 05 Month 14 Day
Last modified on
2018 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009273

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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