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.
Parallel
Deferiprone (DFP)
DrugThis intervention has not been used before on Schizophrenia or Schizoaffective patients with predominant negative symptoms.
N-Acetyl Cysteine (NAC)
DrugThis drug is given to both groups.
Change in Total PANSS Score
Change from Baseline to Week 36 in the PANSS (Positive and Negative Syndrome Scale) total score. PANSS total score range: 30 to 210 (30 items, each rated 1-7, so minimum 30 and maximum 210). Higher scores indicate more severe symptoms.
PANSS Marder Negative Symptom Factor Score
Change from Baseline in the PANSS Marder Negative Symptom Factor Score (NSF)
PANSS Positive Subscale Score
Change from Baseline in the PANSS Positive sub-scale score
PANSS Negative Subscale Score
Change from Baseline in the PANSS Negative sub-scale score
PANSS General Psychopathological Subscale Score
Change from Baseline in the PANSS General Psychopathological sub-scale score
Proportion of patients showing a PANSS response of ≥30% reduction
Proportion of patients showing a PANSS response of ≥30% reduction in corrected PANSS total score (PANSS total minus 30)
CDSS (Calgary Depression Scale for Schizophrenia) Scale
Change from Baseline in CDSS (Calgary Depression Scale for Schizophrenia) scale
CGI-Schizophrenia (CGI-SCH) : Negative Symptoms Severity of Illness sub-scale
Change from Baseline in the CGI-Schizophrenia (CGI-SCH) Scale : Negative Symptoms - Severity of Illness sub-scale; Scale: 1-7; 1 = Normal, not ill; 7 = Among the most extremely ill patients
CGI-Schizophrenia (CGI-SCH) : Overall Severity of Illness sub-scale
Change from Baseline in the CGI-Schizophrenia (CGI-SCH) Scale : Overall Severity of Illness sub-scale; Scale: 1-7; 1 = Normal, not ill; 7 = Among the most extremely ill patients
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Amit Lotan
Lead sponsor
Hadassah Medical Organization
Sponsor institution
Hadassah Medical Organization
Collaborator
Jerusalem Mental Health Center
Collaborator
Hebrew University of Jerusalem
Collaborator
