UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004008 |
|---|---|
| Receipt number | 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 09:29:48 |
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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
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
r2kugimiya@marianna-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry
St. Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004747
