Status:
UNKNOWN
High Dose D-Serine as Adjuvant Treatment for Recent Onset Schizophrenia
Lead Sponsor:
Hadassah Medical Organization
Collaborating Sponsors:
Herzog Hospital
Conditions:
Schizophrenia
Eligibility:
All Genders
18-30 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare efficacy and safety of add-on treatment with a moderately high dose of D-serine, an NMDA-glycine site agonist, in young, recent onset schizophrenia patients who...
Detailed Description
Background: Recent advances in understanding the neurobiology underlying schizophrenia have underscored a pivotal role for a specific receptor for the neurotransmitter glutamate, the NMDA receptor, wh...
Eligibility Criteria
Inclusion
- Age 18-30
- Diagnosis of schizophrenia/schizoaffective disorder
- Recent onset (up to five years since onset of positive symptoms)
- Stable dose antipsychotic treatment for at least 4 weeks
- Baseline PANSS total score of at least 70
- Baseline PANSS negative subscale score of at least 20
- Clinically stable (stable CGI score for two consecutive weeks)
Exclusion
- Criteria for other DSM-IV Axis I diagnoses are met
- Lifetime history of alcohol or substance dependence
- Alcohol or substance abuse within the past year
- Judged clinically to be at suicidal or homicidal risk
- Female patients who are pregnant or lactating.
- Patients with known intolerance to D-serine treatment
- Patients treated with ECT within 12 weeks prior to study entry
- Patients treated with TMS within 4 weeks prior to study entry
- Patients suffering from an unstable and/or untreated medical disorder
- Patients suffering from renal or hepatic dysfunction
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2014
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01459029
Start Date
November 1 2011
End Date
October 1 2014
Last Update
October 25 2011
Active Locations (2)
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1
Ezrath Nashim - Herzog Memorial Hospital & Community Clinics
Jerusalem, Israel
2
Hadassah Medical Organization
Jerusalem, Israel