Safety and Effectiveness of D-serine in Schizophrenia

Completed · Phase 2

Conditions studied: Schizophrenia

In brief

This study will determine whether increasing D-serine within the body will improve negative symptoms and cognitive impairments in people with schizophrenia.

Key facts

Study ID

NCT00322023

Run by

Nathan Kline Institute for Psychiatric Research

People needed

55

Starts

2006-03-01

Expected to finish

2009-01-01

Last updated by the study team

2020-10-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States
• The Zucker Hillside Hospital — Glen Oaks, New York, United States
• The Nathan S. Kline Institute for Psychiatric Research — Orangeburg, New York, United States

Full record on ClinicalTrials.gov

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