A randomized, double-blind, placebo-controlled, crossover trial of D-cycloserine in schizophrenic patients with the conventional antipsychotic medication

UMIN ID: UMIN000000468

Registered date:18/08/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Schizophrenia
• Date of first enrollment: 2006/09/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

D-cycloserine 25mgX2/day
placebo

Outcome(s)

• Primary Outcome: 1) PANSS (Scores of positive, negative, and total symptoms) 2) SANS (Scores of negative symptoms)
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Tokyo Medical and Dental University
• Source(s) of Monetary Support: Ministry of Education, Science and Culture, Japan/Tokyo Medical and Dental University