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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000468
Receipt No. R000000568
Scientific Title A randomized, double-blind, placebo-controlled, crossover trial of D-cycloserine in schizophrenic patients with the conventional antipsychotic medication
Date of disclosure of the study information 2006/08/18
Last modified on 2015/05/02

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Basic information
Public title A randomized, double-blind, placebo-controlled, crossover trial of D-cycloserine in schizophrenic patients with the conventional antipsychotic medication
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 with the conventional antipsychotic medication
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 (Scores of positive, negative, and total symptoms)
2) SANS (Scores of negative symptoms)
Key secondary outcomes 1) PANSS (Scores of the individual subgroups of positive symptoms)
2) PANSS (Scores of the individual subgroups of negative symptoms)
3) SANS (Scores of the individual subgroups of negative symptoms)
4) GAS (Scores of the Global Assessment Scale)
5) HAM-D (Scores of the Hamilton Rating Scale for Depression)
6) DIEPSS (Scores of the Drug-Induced Extra-Pyramidal Symptoms Scale)
7) AIMS (Scores of the Abnormal Involuntary Movement Scale)
8) EQS (Scores of the Emotional Intelligence Scale)
9) The serum levels of D-cycloserine
10) The serum levels of D-serine
11) Brain MRI

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 NO
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 25mgX2/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 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Nishikawa
Organization Tokyo Medical and Dental University Graduate School
Division name Section of Psychiatry and Behavioral Sciences
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL 03-5803-5237
Email tnis.psyc@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Nishikawa
Organization Tokyo Medical and Dental University Graduate School
Division name Department of Psychiatry and Behavioral Sciences
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL 03-5803-5237
Homepage URL
Email tnis.psyc@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
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
2006 Year 08 Month 18 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
2005 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2006 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 08 Month 13 Day
Last modified on
2015 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000568

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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