D-Serine Monotherapy for Schizophrenia
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
D-serine 2100 mg daily
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, NMDA, D-serine
Eligibility Criteria
Inclusion Criteria: DSM-IV criteria for chronic schizophrenia Treatment resistant aged 18-70 Two months on stable risperidone dose PANSS positive symptom cluster score >20 PANSS negative symptom cluster score >22 Exclusion Criteria: Substance abuse Concurrent DSM IV axis I disorder Serious medical disorder Concurrent drug therapy that can obscure the effect of risperidone or DSR.
Sites / Locations
- Herzog Hospital, Department of PsychiatryRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00215917
Brief Title
D-Serine Monotherapy for Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Herzog Hospital
4. Oversight
5. Study Description
Brief Summary
N-methyl-D-aspartate receptor (NMDAR) agonist, added to classical or atypical antipsychotic medication, has reduced negative, depressive, and cognitive symptomatology. We will be investigating the effect of D-serine, (DSR), a selective and potent NMDAR agonist, as monotherapy for treatment resistant schizophrenics.
40 subjects on stable doses of risperidone will be randomized under double-blind conditions into a treatment group, which will receive D-serine 2100 mg, or a control group, which will continue to receive risperidone. Treatment will continue for 14 weeks.
Symptoms and side effects will be rated biweekly with the CGI, PANSS, BPRS, SAS, AIMS, and UKU. Before and after the trial subjects will undergo neuropsychological assessments. Baseline and post-trial levels of amino acids relevant to glutamatergic neurotransmission (glutamate, glutamine, aspartate, glycine, serine, alanine) will be assessed.
The primary outcome measures of the study will be the PANSS total scores and the positive and negative symptom cluster scores.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, NMDA, D-serine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
D-serine 2100 mg daily
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-IV criteria for chronic schizophrenia
Treatment resistant
aged 18-70
Two months on stable risperidone dose
PANSS positive symptom cluster score >20
PANSS negative symptom cluster score >22
Exclusion Criteria:
Substance abuse
Concurrent DSM IV axis I disorder
Serious medical disorder
Concurrent drug therapy that can obscure the effect of risperidone or DSR.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pesach Lichtenberg, M.D.
Phone
972-2-6221154
Email
licht@cc.huji.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pesach Lichtenberg, M.D.
Organizational Affiliation
Herzog Hospital, and Hadassah Medical School--the Hebrew University of Jerusalem, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzog Hospital, Department of Psychiatry
City
Jerusalem
ZIP/Postal Code
91351
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pesach Lichtenberg, M.D.
Phone
972-2-5316929
Email
licht@cc.huji.ac.il
12. IPD Sharing Statement
Learn more about this trial
D-Serine Monotherapy for Schizophrenia
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