D-serine Monotherapy for Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
D-serine
Olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, treatment resistance, D-serine, Olanzapine, treatment refractory schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Age 18-70;
- Diagnosis of schizophrenia/schizoaffective disorder according to DSM-IV criteria.
- Stable dose antipsychotic treatment for at least 4 weeks;
- Treatment refractoriness according to Kane et al.(1988) criteria.
Exclusion Criteria:
- Meeting criteria for other DSM-IV Axis I diagnoses ;
- Substance abuse or alcoholism during entire lifetime;
- Are judged clinically to be at suicidal or homicidal risk;
- Female patients who are pregnant or lactating; female patients who are not pregnant or lactating, if sexually active, must be using medically accepted means of contraception;
- Patients with known intolerance to OLA treatment or who have failed an adequate trial of OLA (at least 6 weeks) at high doses (20 mg/day or higher);
- Patients treated with depot antipsychotics or ECT within the eight weeks prior to study entry.
Sites / Locations
- Ezrath Nashim - Herzog Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
D-serine arm
Olanzapine arm
Arm Description
6 week fixed dose phase with D-serine 1500 mg/day to be increased starting from week two to 3000 mg/day followed by a 4 week flexible dose phase allowing for two 500 mg/day dose changes.
6 week fixed dose phase with Olanzapine 15 mg/day to be increased starting from week two to 30 mg/day followed by a 4 week flexible dose phase allowing for two 5 mg/day dose changes.
Outcomes
Primary Outcome Measures
PANSS change scores.
side effects
Secondary Outcome Measures
% treatment responders
Full Information
NCT ID
NCT00816894
First Posted
January 1, 2009
Last Updated
December 9, 2013
Sponsor
Herzog Hospital
Collaborators
Israel Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00816894
Brief Title
D-serine Monotherapy for Schizophrenia
Official Title
D-serine Antipsychotic Monotherapy for Treatment Refractory Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herzog Hospital
Collaborators
Israel Science Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A first generation of clinical studies, performed during the last decade, demonstrates that adjuvant treatment with compounds that enhance NMDAR-mediated neurotransmission due to their agonistic activity at the NMDAR-associated glycine (GLY) site (e.g. GLY, D-serine (DSR)) leads to significant symptom reductions in chronic schizophrenia patients.Furthermore, preliminary findings suggest that treatment with NMDAR-GLY site modulators may also be beneficial as antipsychotic monotherapy In the proposed project, during a three year period, 60 schizophrenia patients that fulfill treatment resistance criteria will be randomly entered in a 10 week, two phase (fixed/flexible dose), parallel group, double blind controlled study assessing the efficacy of olanzapine (OLA) (up to 40 mg/day) vs. DSR (up to 4000 mg/day) as antipsychotic monotherapy.Clinical, neurocognitive, electrophysiological, and amino acids (i.e. GLY, DSR) levels assessments will be performed during the study. The specific aims of the proposed project are: 1) to assess the efficacy and safety of DSR as a new medication for treatment refractory schizophrenia, and 2) to assess DSR effects in terms of relevant amino acids serum levels, neurocognitive performance, and relevant brain electrophysiological parameters. The overall importance of the proposed project consists of its potential to lay the foundations for an innovative type of intervention for treatment resistant schizophrenia patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, treatment resistance, D-serine, Olanzapine, treatment refractory schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D-serine arm
Arm Type
Experimental
Arm Description
6 week fixed dose phase with D-serine 1500 mg/day to be increased starting from week two to 3000 mg/day followed by a 4 week flexible dose phase allowing for two 500 mg/day dose changes.
Arm Title
Olanzapine arm
Arm Type
Active Comparator
Arm Description
6 week fixed dose phase with Olanzapine 15 mg/day to be increased starting from week two to 30 mg/day followed by a 4 week flexible dose phase allowing for two 5 mg/day dose changes.
Intervention Type
Drug
Intervention Name(s)
D-serine
Other Intervention Name(s)
DSR
Intervention Description
6 week fixed dose phase with D-serine 1500 mg/day to be increased starting from week two to 3000 mg/day followed by a 4 week flexible dose phase allowing for two 500 mg/day dose changes
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
6 week fixed dose phase with Olanzapine 15 mg/day to be increased starting from week two to 30 mg/day followed by a 4 week flexible dose phase allowing for two 5 mg/day dose changes.
Primary Outcome Measure Information:
Title
PANSS change scores.
Time Frame
~ biweekly throughout the study
Title
side effects
Time Frame
~ biweekly throughout the study
Secondary Outcome Measure Information:
Title
% treatment responders
Time Frame
End of the study
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:
Age 18-70;
Diagnosis of schizophrenia/schizoaffective disorder according to DSM-IV criteria.
Stable dose antipsychotic treatment for at least 4 weeks;
Treatment refractoriness according to Kane et al.(1988) criteria.
Exclusion Criteria:
Meeting criteria for other DSM-IV Axis I diagnoses ;
Substance abuse or alcoholism during entire lifetime;
Are judged clinically to be at suicidal or homicidal risk;
Female patients who are pregnant or lactating; female patients who are not pregnant or lactating, if sexually active, must be using medically accepted means of contraception;
Patients with known intolerance to OLA treatment or who have failed an adequate trial of OLA (at least 6 weeks) at high doses (20 mg/day or higher);
Patients treated with depot antipsychotics or ECT within the eight weeks prior to study entry.
Facility Information:
Facility Name
Ezrath Nashim - Herzog Memorial Hospital
City
Jerusalem
ZIP/Postal Code
91035
Country
Israel
12. IPD Sharing Statement
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D-serine Monotherapy for Schizophrenia
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