In following guidelines for studying negative symptoms in schizophrenia, 60 patients aged 18-40, diagnosed with schizophrenia or schizoaffective disorder during the last ten years, will receive a combination of the iron chelator DFP plus NAC or a matching placebo plus NAC combination, as add-on to their maintenance antipsychotic drug (APD) treatment, for a duration of 36 weeks. Prior to initiation of treatment, all participants will undergo baseline MRI scan. A follow-up MRI will be conducted at the end of the 36-week study period, or upon early withdrawal if applicable, to evaluate the effect of the add-on treatment on iron dyshomeostasis and morphology.
Aged 18-55 years.
Diagnosis of schizophrenia/schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders- Fifth Edition (DSM-5) criteria. The diagnostic assessment will be conducted using the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT).
Adequate antipsychotic treatment for ≥ 4 months prior to screening (excluding clozapine use).
Stable dose of antipsychotic medication for ≥ 8 weeks prior to screening (excluding clozapine use).
Primary DSM-5 diagnosis other than schizophrenia or schizoaffective disorder in the 12 months prior to screening, according to SCID-5-CT.
Subjects diagnosed with Autistic Spectrum Disorder (ASD).
Subjects diagnosed with Intellectual Developmental Disorder.
Patients who received clozapine within the 6 months preceding the screening.
Amit Lotan
Lead sponsor
Hadassah Medical Organization
Sponsor institution
Hadassah Medical Organization
Collaborator
Jerusalem Mental Health Center
Collaborator
Hebrew University of Jerusalem
Collaborator