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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005186
Enrollment
30
Registered
2011-03-03
Start date
2011-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

D-cycloserine 25mg x 2/day placebo

Sponsors

Tokyo Medical and Dental University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
1) PANSS:Changes in total scores 2) SANS:Changes in total scores

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactTetsuro Ohmori

Tokushima University Hospital Psychiatry

088-633-7130

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026