UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005186 |
|---|---|
| Receipt number | R000006144 |
| Scientific Title | A randomized, double-blind, placebo-controlled, crossover trial of D-cycloserine in schizophrenic patients |
| Date of disclosure of the study information | 2011/03/03 |
| Last modified on | 2011/08/12 10:18:06 |
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Basic information
Public title
A randomized, double-blind, placebo-controlled, crossover trial of D-cycloserine in schizophrenic patients
Acronym
A double-blind, placebo-controlled, crossover trial of D-cycloserine in schizophrenic patients
Scientific Title
A randomized, double-blind, placebo-controlled, crossover trial of D-cycloserine in schizophrenic patients
Scientific Title:Acronym
A double-blind, placebo-controlled, crossover trial of D-cycloserine in schizophrenic patients
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of facilitation of the NMDA type glutamate receptor function by D-cycloserine on the antipsychotic-resistant symptoms of schizophrenia, we will conduct the clinical study that the schizophrenic patients treated with the ordinary antipsychotic drugs will participated in a double-blind, placebo-controlled, crossover trial of 50 mg/day D-cycloserine added to their medication. The clinical efficacy will be compared 1) between the patients treated with placebo and those with D-cycloserine, and 2) between the placebo-treated period and the D-cycloserine-treated period in the individual patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) PANSS:Changes in total scores
2) SANS:Changes in total scores
Key secondary outcomes
1) PANSS:Changes in total scores
2) PANSS:Total scores
3) PANSS:Changes in subscale scores
4) SANS:Changes in total scores
5) SANS:Total scores
6) SANS:Changes in subscale scores
7) GAS:Scores of the Global Assessment Scale
8) JCDSS:Scores of the Japanese version of the Calgary Depression Scale for Schizophrenia
9) DIEPSS:Scores of the Drug-Induced Extra-Pyramidal Symptoms Scale
10) Edinburgh inventory
11) AIMS:Scores of the Abnormal Involuntary Movement Scale
12) EQS:Scores of the Emotional Intelligence Scale
13) BACS:Scores of the Brief Assessment of Cognition in Schizophrenia
14) MCCB-J:Scores of the Japanese version of the MATRICS Consensus Cognitive Battery
15) The serum levels of D-cycloserine
16) The serum levels of D-serine
17) Brain MRI
18) Brain MR spectroscopy
19) The pattern of changes in NIRS signals during frontal cortex activation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
D-cycloserine 25mg x 2/day
Interventions/Control_2
placebo
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects are all inpatients who fulfilled the following inclusion criteria:
1)DSM-IV (American Psychiatric Association 1994) diagnosis of schizophrenia;
2) 20-70 years old;
3) men and women;
4) outpatients and inpatients;
5) written informed consent is obtained from patients themselves after the description and explanations of the study to them orally and in writing.
Key exclusion criteria
Patients who meet the following criteria should be excluded:
1) under being treated with the structured psychotherapies or cognitive-behavioral therapies within 12 weeks before the beginning of this study;
2) DSM-IV diagnosis of substance-related disorders within 24 weeks before the beginning of this study;
3) under being treated with the electroconvulsive therapy within 12 weeks before the beginning of this study;
4) during pregnancy and lactation or the possible pregnancy within 30 days after the end of this study;
5) suicide attempt within 24 weeks before the beginning of this study;
6) history or complication of convulsive disorders;
7) history of hypersensitivity to D-cycloserine or lactose;
8) complication of serious organic brain diseases;
9) complication of serious somatic disorders including hepatopathy, nephropathy, cardiopathy, etc.;
10) implantation of metal materials in the body;
11) insertion of a cardiac pacemaker;
12) under being treated with D-cycloserine;
13) other conditions that are considered to be inappropriate to the present trial by its investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuro Ohmori |
Organization
Tokushima University Hospital
Division name
Psychiatry
Zip code
Address
2-50-1, Kuramoto-cho, Tokushima 770-8503, Japan
TEL
088-633-7130
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuro Ohmori |
Organization
Tokushima University Hospital
Division name
Psychiatry
Zip code
Address
2-50-1, Kuramoto-cho, Tokushima 770-8503, Japan
TEL
088-633-7130
Homepage URL
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Science and Culture, Japan/Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
徳島大学病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | 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 | 03 | Month | 03 | Day |
Last modified on
| 2011 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006144
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