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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004008
Receipt No. R000004747
Scientific Title Effects of discontinuation of long-term benzodiazepine use on cognitive function in schizophrenia
Date of disclosure of the study information 2010/09/01
Last modified on 2012/02/06

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Basic information
Public title Effects of discontinuation of long-term benzodiazepine use on cognitive function in schizophrenia
Acronym Effects of discontinuation of benzodiazepine on cognitive function in schizophrenia (BZD discontinuation study)
Scientific Title Effects of discontinuation of long-term benzodiazepine use on cognitive function in schizophrenia
Scientific Title:Acronym Effects of discontinuation of benzodiazepine on cognitive function in schizophrenia (BZD discontinuation study)
Region
Japan

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

Objectives
Narrative objectives1 The high use of long-term anxiolytic drugs (benzodiazepines) with antipsychotics has been identified as an important issue in the treatment of schizophrenia in Japan. The aim of this study was to evaluate the effects of gradual discontinuation of benzodiazepines on cognitive function and clinical symptoms in schizophrenia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Cognitive function:
Brief Assessment of Cognition in Schizophrenia-Japanese version (BACS-J)

Key secondary outcomes Psychopathology: Positive And Negative Syndrome Scale (PANSS), Clinical Global Impression- Severity (CGI-S)
Subjective QOL: The Schizophrenia Quality of Life Scale -Japanese version (SQLS-J)
Adverse effects: Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 benzodiazepine discontinuation group

Benzodiazepine (BZD) was gradually tapered and discontinued. Dosages of antipsychotic drugs, sedative-hypnotics, antidepressants, and mood stabilizers were not changed during the study. The maximum period for BZD discontinuation was 24 weeks. Clinical assessments were undertaken at baseline and 4 weeks after BZD discontinuation.
Interventions/Control_2 control group

Benzodiazepine was not tapered.
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
18 years-old <=
Age-upper limit
59 years-old >=
Gender Male and Female
Key inclusion criteria 1) aged 18 to 59 years
2) receiving a stable dose of a single second-generation antipsychotics (SGA) and receiving a stable dose of concomitant benzodiazepine in the daytime for at least 3 months
3) schizophrenic patients who gave informed consent after the study procedures had been fully explained
Key exclusion criteria 1) comorbid central nervous system disorder
2) meeting DSM-IV-TR criteria for alcohol or other substance dependence
3) meeting DSM-IV-TR criteria for mental retardation
4) taking tricyclic antidepressants
5) treatment with electroconvulsive therapy in the 3 months preceding the study; and
6) inability to understand the study protocol
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiya Miyamoto
Organization St. Marianna University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 2-16-1, Sugao, Miyamae-ku Kawasaki, Kanagawa 216-8511
TEL 044-977-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Rei Kitajima
Organization St. Marianna University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 2-16-1, Sugao, Miyamae-ku Kawasaki, Kanagawa 216-8511
TEL 044-977-8111
Homepage URL
Email r2kugimiya@marianna-u.ac.jp

Sponsor
Institute Department of Neuropsychiatry
St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization Department of Neuropsychiatry
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Ofuji 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 聖マリアンナ医科大学神経精神科学教室(神奈川県)Department of Neuropsychiatry
St. Marianna University School of Medicine (Kanagawa)
大富士病院(静岡県)Ofuji hospital (Shizuoka)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
BZDs were reduced or discontinued safely in most patients, and no emergent withdrawal symptoms were observed. Significant improvements were shown in verbal memory, working memory, and composite score, as measured by the BACS-J without practice effects. In addition, the motivation/energy score on the SQLS-J, the negative symptoms and total scores on the PANSS significantly improved after tapering BZDs.
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
2010 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2012 Year 01 Month 01 Day
Date of closure to data entry
2012 Year 02 Month 01 Day
Date trial data considered complete
2012 Year 02 Month 01 Day
Date analysis concluded
2012 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 06 Day
Last modified on
2012 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004747

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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