CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 104 enrolled
Drug / intervention
D-serine +3 moredrug
Likely dose
D-serine 30 mg/kgAI-extracted
Key inclusion· 1
  • ✓Confirmed diagnosis of schizophrenia or schizoaffective disorder
Key exclusion· 1
  • ✕Pregnant or lactating women

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00237809
NCT00237809Phase 3Completed
CompareCT.gov

D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia

Yale University·interventional·Posted Oct 12, 2005·Updated May 10, 2017

In Brief

A Phase 3 clinical trial evaluating D-serine, Cognitive Retraining (CRT), and 2 other interventions for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 104 participants across 2 sites.

Detailed Summary

This study is based on the hypothesis that by increasing N-methyl-D-aspartic acid (NMDA) receptor function in the brain and thereby increasing the capacity of the brain to both form new connections and strengthen existing connections, schizophrenic patients may derive both greater and sustained benefit from cognitive retraining.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder
CountriesUnited States
CollaboratorsNational Alliance for Research on Schizophrenia and Depression, Donaghue Medical Research Foundation

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 12, 2005
Enrollment StartSep 1, 2002
Primary CompletionDec 1, 2010
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 20.7 years ago

Interventions

D-serinedrug

D-serine (30 mg/kg)

Cognitive Retraining (CRT)behavioral

Cognitive retraining therapy (CRT)

Placebodrug

Placebo D-serine Drug

Cognitive Retraining Placebobehavioral

Cognitive retraining therapy (CRT) control