Phase 2
Completed N=55
Safety and Effectiveness of D-serine in Schizophrenia
Schizophrenia
Source: ClinicalTrials.gov NCT00322023 ↗
Enrolled (actual)
55
Serious AEs
2.1%
Results posted
Oct 2020
Primary outcomePrimary: Renal Safety Measures — 0; 0; 1 adverse events
Summary
This study will determine whether increasing D-serine within the body will improve negative symptoms and cognitive impairments in people with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal Safety Measures |
0; 0; 1 | — |
| SECONDARY Positive and Negative Symptoms Scale (PANSS) |
5.1; 4.4; 6.3 | <0.0001 sig |
| SECONDARY Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Battery |
0.8; 3.9; 2.8 | 0.39 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00322023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.