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Combination Therapy of Deferiprone and N-Acetylcysteine for Treating Negative Symptoms in Schizophrenia

NCT07759895 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-08-12

No results posted yet for this study

Summary

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.

Conditions

  • Schizoaffecitve Disorder
  • Schizophrenia and Schizoaffective Disorder
  • Schizophrenia and Predominant Negative Symptoms

Interventions

DRUG

Deferiprone (DFP)

This intervention has not been used before on Schizophrenia or Schizoaffective patients with predominant negative symptoms.

DRUG

N-Acetyl Cysteine (NAC)

This drug is given to both groups.

Sponsors & Collaborators

  • Hadassah Medical Organization

    collaborator OTHER

  • Jerusalem Mental Health Center

    collaborator OTHER_GOV

  • Hebrew University of Jerusalem

    collaborator OTHER

  • Amit Lotan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07759895 on ClinicalTrials.gov