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A randomized, double-blind, placebo-controlled, crossover trial of D-cycloserine in schizophrenic patients

Not Applicable
Recruiting
Conditions
Schizophrenia
Registration Number
JPRN-UMIN000005186
Lead Sponsor
Tokyo Medical and Dental University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1) PANSS:Changes in total scores 2) SANS:Changes in total scores
Secondary Outcome Measures
NameTimeMethod
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
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