High Dose D-Serine as Adjuvant Treatment for Recent Onset Schizophrenia

• Status: Unknown status
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare efficacy and safety of add-on treatment with a moderately high dose of D-serine, an NMDA-glycine site agonist, in young, recent onset schizophrenia patients who suffer from significant symptoms despite treatment with antipsychotics.

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

Details

• Lead Sponsor: Hadassah Medical Organization
• Collaborator: Herzog Hospital

Criteria

Inclusion Criteria:

• Age 18-30

• Diagnosis of schizophrenia/schizoaffective disorder

• Recent onset (up to five years since onset of positive symptoms)

• Stable dose antipsychotic treatment for at least 4 weeks

• Baseline PANSS total score of at least 70

• Baseline PANSS negative subscale score of at least 20

• Clinically stable (stable CGI score for two consecutive weeks)

Exclusion Criteria:

• Criteria for other DSM-IV Axis I diagnoses are met

• Lifetime history of alcohol or substance dependence

• Alcohol or substance abuse within the past year

• Judged clinically to be at suicidal or homicidal risk

• Female patients who are pregnant or lactating.

• Patients with known intolerance to D-serine treatment

• Patients treated with ECT within 12 weeks prior to study entry

• Patients treated with TMS within 4 weeks prior to study entry

• Patients suffering from an unstable and/or untreated medical disorder

• Patients suffering from renal or hepatic dysfunction