A Phase 2 interventional study of Deferiprone (DFP) and N-Acetyl Cysteine (NAC) in Schizoaffecitve Disorder, Schizophrenia and Schizoaffective Disorder and Schizophrenia and Predominant Negative Symptoms, sponsored by Amit Lotan. Recruiting at 2 sites in Israel. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Amit Lotan · Phase 2, Interventional, and Treatment
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.
The present study is designed as an interventional trial over a 36-week period per patient. The target populThe present study is designed as an interventional trial over a 36-week period per patient. The target population consists of patients with schizophrenia (age 18-40 years), up to ten years since onset of positive symptoms. The overall objective of the study is to assess the safety and efficacy of DFP-NAC combination add-on in patients with schizophrenia, compared to NAC-only add-on (control group). This study is designed to test the hypothesis that, in patients with prominent negative symptoms, adjunctive treatment with DFP-NAC combination will demonstrate a favorable safety profile and produce clinical improvements in negative and cognitive domains of schizophrenia beyond those offered by addition of NAC alone.ation consists of patients with schizophrenia (age 18-40 years), up to ten years since onset of positive symptoms. The overall objective of the study is to assess the safety and efficacy of DFP-NAC combination add-on in patients with schizophrenia, compared to NAC-only add-on (control group). This study is designed to test the hypothesis that, in patients with prominent negative symptoms, adjunctive treatment with DFP-NAC combination will demonstrate a favorable safety profile and produce clinical improvements in negative and cognitive domains of schizophrenia beyond those offered by addition of NAC alone.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 80 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →This is the only study on the registry with Amit Lotan as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For males or women, either of the following:
i. An evaluation of potential underlying causes as well as potentially comorbid deficiencies has been completed, including assessment of folate, vitamin B12, celiac antibodies and H. pylori infection, and, in patients over 40 years old or with positive family history of colorectal cancer, also an appropriate colorectal screening test, alongside other tests deemed as relevant by the investigator; ii. Identified causes have been appropriately managed; iii. Repeated ferritin assessment prior to randomization remains within the range of 15-29 ng/mL; and iv. Oral iron supplementation is initiated according to the study protocol.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: N-Acetyl Cysteine (NAC)
Drug: Deferiprone (DFP) · Drug: N-Acetyl Cysteine (NAC)
This intervention has not been used before on Schizophrenia or Schizoaffective patients with predominant negative symptoms.
This 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.
Time frame: 36 Weeks (LOCF)
PANSS Marder Negative Symptom Factor Score
Change from Baseline in the PANSS Marder Negative Symptom Factor Score (NSF)
Time frame: 12, 24 and 36 weeks
PANSS Positive Subscale Score
Change from Baseline in the PANSS Positive sub-scale score
Time frame: 12, 24 and 36 weeks
PANSS Negative Subscale Score
Change from Baseline in the PANSS Negative sub-scale score
Time frame: 12, 24 and 36 weeks
PANSS General Psychopathological Subscale Score
Change from Baseline in the PANSS General Psychopathological sub-scale score
Time frame: 12, 24 and 36 weeks
BNSS (Brief Negative Symptom Scale) Score
Change from Baseline in the BNSS (Brief Negative Symptom Scale) score
Time frame: 12, 24 and 36 weeks
BACS (Brief Cognitive Assessment in Schizophrenia) Score
Change from Baseline in the BACS (Brief Cognitive Assessment in Schizophrenia) score
Time frame: 12, 24 and 36 weeks
Reported adverse events (descriptive)
Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
Weight (kg)
Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
Height (cm)
Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
BMI (Body Mass Index, kg/cm^2)
Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
Blood pressure (mm Hg)
Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
Heart rate (BPM)
Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
Electrocardiogram (ECG)
Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
Complete Blood Count (CBC)
Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
Serum creatinine
kidney function test, mg/dL, Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
Serum alanine transaminase
ALT, liver function test, U/L, Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
Serum ferritin
iron store index, ng/mL, Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
Simpson-Angus Extrapyramidal Rating Scale (SAS)
10 items, each 0-4, Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
Barnes Akathisia Rating Scale (BARS)
Global clinical assessment of akathisia (0-5), Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
Abnormal Involuntary Movement Scale (AIMS)
Items counted: 7, Per-item range: 0-4, Total (sum) range: 0-28, Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Ideation severity: 0-5, Ideation intensity (sum): 0-25, Behavior: categorical (yes/no; counts), Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
Udvalg for Kliniske Undersøgelser Side Effect Rating Scale (UKU-SERS )
Per item range: 0-3 (0 = none, 1 = mild, 2 = moderate, 3 = marked/severe), Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
Discontinuation-Emergent Signs and Symptoms (DESS)
43-item checklist: each symptom is scored 0/1 (absent/present), total range 0-43; Safety and tolerability assessment
Time frame: From enrollment to the end of treatment at 36 weeks
Quantitative MRI - Proton Density (PD)
PD is normalized to derive the water fraction (WF); WF yields the Macromolecular Tissue Volume (MTV). These reflect the ratio of water to non water tissue and act as biomarkers of atrophy or density
Time frame: baseline, 36 weeks
Quantitative MRI - R1 (Longitudinal Relaxation Rate)
R1 is sensitive to myelin, iron and water content. R1 and MTV are acquired using the same variable flip angle or/and MP2RAGE sequences, which can also include MT and multi echo acquisitions for R2\* and QSM
Time frame: Baseline, 36 weeks
Quantitative MRI - Magnetization Transfer (MT)
MT modeling estimates the macromolecular contribution to R1, yielding MTsat. Combined with R1 and MTV, this enables R1sat and MTVsat estimation, providing contrast related to saturated vs. unsaturated water pools
Time frame: Baseline, 36 weeks
Quantitative MRI - R2*
R2\* is influenced by magnetic field inhomogeneities and is sensitive to iron deposition and other sources
Time frame: Baseline, 36 weeks
Quantitative MRI - Quantitative Susceptibility Mapping (QSM)
QSM estimates tissue magnetic susceptibility from R2\* data and is sensitive to iron, calcium and related tissue properties
Time frame: Baseline, 36 weeks
Quantitative MRI - R2 (Transverse Relaxation Rate)
R2 reflects tissue integrity and is influenced by myelin and iron. Multi-component fitting allows estimation of Myelin Water Fraction (MWF)
Time frame: Baseline, 36 weeks
Quantitative MRI - R1-R2 Relaxivity
The voxel-wise slope of R1 vs. R2\* within an ROI (R1-R2\* relaxivity) can reflect specific iron forms
Time frame: Baseline, 36 weeks
Quantitative MRI - Tissue Relaxivity (MTV Dependency)
Parameter-MTV slope (MDM: Multidimensional Dependency on MTV) reflects lipid and macromolecular composition
Time frame: Baseline, 36 weeks
Quantitative MRI - Diffusion MRI
Mean Diffusivity (MD)
Time frame: Baseline, 36 weeks
Quantitative MRI - Diffusion MRI
Fractional Anisotropy (FA)
Time frame: Baseline, 36 weeks
Quantitative MRI - G-Ratio Mapping
Combines diffusion (axon density) and qMRI (myelin) data to estimate the g-ratio: the ratio of axon to fiber diameter
Time frame: Baseline, 36 weeks
Quantitative MRI - Macroscopic Morphometry
Cortical volume
Time frame: Baseline, 36 weeks
Quantitative MRI - Neuromelanin-Sensitive MRI (NM-MRI)
T1-weighted or MT-enhanced sequences detect neuromelanin in the substantia nigra and locus coeruleus; used to assess catecholaminergic neuron integrity
Time frame: Baseline, 36 weeks
Magnetic Resonance Spectroscopy (MRS)
Estimates concentrations of brain metabolites
Time frame: Baseline, 36 weeks
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)
Time frame: 12, 24 and 36 weeks
CDSS (Calgary Depression Scale for Schizophrenia) Scale
Change from Baseline in CDSS (Calgary Depression Scale for Schizophrenia) scale
Time frame: 12, 24 and 36 weeks
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
Time frame: 12, 24 and 36 weeks
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
Time frame: 12, 24 and 36 weeks
CGI-Schizophrenia (CGI-SCH) : Overall Degree of Change sub-scale
Change from Baseline in the CGI-Schizophrenia (CGI-SCH) Scale : Overall Degree of Change sub-scale; Scale: 1-7, 1 = Very much improved, 4 = No change, 7 = Very much worse
Time frame: 12, 24 and 36 weeks
Personal and Social Performance (PSP) Scale
Change from Baseline in Personal and Social Performance (PSP) scale
Time frame: 12, 24 and 36 weeks
Self-evaluation of Negative Symptoms (SNS) Scale
Change from Baseline in the Self-evaluation of Negative Symptoms (SNS) scale
Time frame: 12, 24 and 36 weeks
Plan to share: Undecided
Started Aug 2026 (actual). Primary completion is estimated for Dec 2028, 28 months after the start.
Of 44 non-industry phase 2 interventional studies under Schizophrenia, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 73. This study's planned 28 months is below that.
Counting every sponsor, half of 101 studies reached it within 25 months; a quarter within 15 and three quarters within 42.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Aug 2026, on Sep 29, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Deferiprone