Status:
COMPLETED
Safety and Effectiveness of D-serine in Schizophrenia
Lead Sponsor:
Nathan Kline Institute for Psychiatric Research
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This study will determine whether increasing D-serine within the body will improve negative symptoms and cognitive impairments in people with schizophrenia.
Detailed Description
Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or ha...
Eligibility Criteria
Inclusion
- Structured Clinical Interview for DSM-III-R diagnosis of schizophrenia or schizoaffective disorder
- PANSS 3 factor negative symptom inclusion score greater than 20 prior to study entry
- PANSS total score between 60 and 110
- Simpson-Angus Scale total score of 12 or less
- Calgary Depression Inventory total score of 10 and suicide score less than 2
- No change in Clinical Global Impressions (CGI) Scale score prior to study entry
- Chlorpromazine (CPZ) equivalent of 1500 or less
- Willing to use an effective form of birth control throughout the study if sexually active
Exclusion
- High extrapyramidal symptom (EPS) levels
- Began, discontinued, or adjusted psychotropic medication within 2 weeks of study entry
- Taking investigational medication within 2 weeks of study entry
- Contraindication to study medication
- Serious or unstable medical illness
- Pregnant or breastfeeding
- Alcohol or drug abuse within 6 months of study entry
- Diagnosed with neurodegenerative disease or a seizure disorder
- History of a kidney impairment
- Currently taking clozapine
- Currently taking more than two antipsychotic medications
- Currently taking stimulants or cholinesterase inhibitors
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00322023
Start Date
March 1 2006
End Date
January 1 2009
Last Update
October 5 2020
Active Locations (3)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06512
2
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
3
The Nathan S. Kline Institute for Psychiatric Research
Orangeburg, New York, United States, 10962