Safety and Effectiveness of D-serine in Schizophrenia

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nathan Kline Institute for Psychiatric Research; National Institute of Mental Health (NIMH)
• Collaborator: National Institute of Mental Health (NIMH)

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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