Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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D-serine 2100 mg daily
Eligibility Criteria
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Inclusion Criteria
2. Treatment resistant
3. aged 18-70
4. Two months on stable risperidone dose
5. PANSS positive symptom cluster score \>20
6. PANSS negative symptom cluster score \>22
Exclusion Criteria
2. Concurrent DSM IV axis I disorder
3. Serious medical disorder
4. Concurrent drug therapy that can obscure the effect of risperidone or DSR.
18 Years
70 Years
ALL
No
Sponsors
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Herzog Hospital
OTHER
Principal Investigators
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Pesach Lichtenberg, M.D.
Role: PRINCIPAL_INVESTIGATOR
Herzog Hospital, and Hadassah Medical School--the Hebrew University of Jerusalem, Israel
Locations
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Herzog Hospital, Department of Psychiatry
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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lichtenberg1CTIL
Identifier Type: -
Identifier Source: org_study_id