Schizoaffecitve DisorderPhase 2IronManNCT07759895
Combination Therapy of Deferiprone and N-Acetylcysteine for Treating Negative Symptoms in Schizophrenia
A Phase 2 study testing Deferiprone (DFP) and N-Acetyl Cysteine (NAC) in people with Schizoaffecitve Disorder and Schizophrenia and Schizoaffective Disorder, run by Amit Lotan at 2 sites in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizoaffecitve Disorder, Schizophrenia and Schizoaffective Disorder, Schizophrenia and Predominant Negative Symptoms
- What is being tested?
- Deferiprone (DFP) and N-Acetyl Cysteine (NAC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesIsrael
- Study dates
- 12 Aug 2026to Dec 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
- When relevant, stable dose of antidepressants, mood stabilizers and benzodiazepines/Z-drugs for ≥ 8 weeks prior to screening.
- Screening and baseline PANSS total score ranging from 60 to 120.
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- Sum ≥ 20 for the 7 items in the Negative Symptoms subscale of the PANSS.
- At least two items in the PANSS Negative Symptoms subscale scored ≥ 4.
- Sum < 20 for the 7 items in the Positive Symptoms subscale of the PANSS.
- Score ≤ 5 for each item in the Positive Symptoms subscale of the PANSS.
- Calgary Depression Schizophrenia Scale (CDSS) score of ≤ 6.
- Persistent and predominant negative symptoms for ≥ 6 months, in the opinion of the investigator
- The subject exhibits clinical stability in both positive and negative symptoms of schizophrenia over the past 6 months, as assessed by the treating psychiatrist and supported by documentation in the medical record.
- No incarceration in prison or acute crisis intervention due to symptom exacerbation within 6 months of screening. The subject must be considered psychiatrically stable in the opinion of the investigator.
- For males or postmenopausal women, either of the following:
- Serum ferritin ≥30 ng/mL at screening. OR
- Serum ferritin 15-29 ng/mL at screening, provided that:
- 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 clinically significant 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.
- For premenopausal women: Serum ferritin ≥15 ng/mL at screening.
- Screening serum hemoglobin ≥ 13g/dL for males, ≥ 12g/dL for females
- Use of contraceptives in women of childbearing age.
- Ability to provide informed consent, confirmed by a non-study psychiatrist. When a subject is under guardianship, both patient assent and guardian consent are required. Obtaining written informed consent, dated and signed, is mandatory prior to the initiation of any procedures related to the clinical trial.
- Ability to safely undergo MRI scanning, assessed by a non-study psychiatrist.
- In the Investigator's opinion, the subject can understand the nature of the trial, comply with study drug administration and protocol procedures or has a guardian able to assist.
- Availability of a reliable caregiver or other responsible person (e.g., family member, social worker, nurse) to support treatment adherence and provide collateral information for rating scales.
Who cannot join
- 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.
- Patients with a history of relapsing neutropenia (Absolute Neutrophile Count (ANC) < 1,500 cells/µL)
- Screening ANC ≤ 2,000 cells/µL.
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- Non-compliance during run-in period (percent adherence ≤ 80%, as examined by pill count).
- Improvement > 20% in PANSS total score or PANSS negative subscale during the run-in period.
- Suicide attempt or serious suicidal behavior within the past 12 months.
- Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and Columbia-Suicide Severity Rating Scale (C-SSRS).
- The subject has a history of substance use disorder or any illicit drug use (other than nicotine) within the past 3 years.
- Positive urine drug screen for drugs of abuse (cocaine, methadone, amphetamines, cannabinoids, opiates, and barbiturates).
- Risk of violent behavior in the opinion of the Investigator.
- Known hypersensitivity to deferiprone or N-Acetylcysteine.
- Pregnancy or intention to become pregnant during the study duration.
- Female patients who are lactating.
- ECT treatment within 18 weeks prior to screening and study entry.
- Patient with substantially confounding extrapyramidal symptoms (according to screening SAS, BARS, AIMS score).
- Conditions that are not suitable for partaking in an MRI scan, including metal implants and incompatible devices.
- Subjects with BMI ≤ 18 or ≥ 40.
- Participation in another clinical trial involving investigational drugs within 3 months prior to screening.
- Clinically significant general medical conditions (neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, oncologic) that could interfere with participation.
- Major active contagious disease.
- Patients with clinically significant abnormalities in hematology, blood chemistry, ECG or physical examination, not resolved by the Baseline visit, that can interfere with study participation.
- Any condition that, in the investigator's judgment, may compromise subject safety or interfere with study assessments.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel2 sites, 2 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
Shlomo Rachmani, +972-2-6777184, shlomo80@hadassah.org.il
- Not yet recruiting
Jerusalem Mental Health Center
Jerusalem
Yoav Kohn, +972-2-6551303 ext. 1803, yoavk@ekmd.huji.ac.il
About this study
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.
Read the detailed description
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.
- Conditions
- Schizoaffecitve Disorder, Schizophrenia and Schizoaffective Disorder, Schizophrenia and Predominant Negative Symptoms
- Being tested
- Deferiprone (DFP), N-Acetyl Cysteine (NAC)
- Keywords
- Deferiprone, N-acetylcysteine, Schizophrenia, Clinical Trial, negative symptoms
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferiprone (DFP)Drug
This intervention has not been used before on Schizophrenia or Schizoaffective patients with predominant negative symptoms.
N-Acetyl Cysteine (NAC)Drug
This drug is given to both groups.
| Study group | Role | What they receive |
|---|---|---|
| Placebo + N-Acetylcysteine | Placebo comparator | Not described Receives: Drug: N-Acetyl Cysteine (NAC) |
| Deferiprone + N-Acetylcysteine | Active comparator | Not described Receives: Drug: Deferiprone (DFP); Drug: N-Acetyl Cysteine (NAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 Weeks (LOCF)
Secondary outcomes (37)
PANSS Marder Negative Symptom Factor Score
Change from Baseline in the PANSS Marder Negative Symptom Factor Score (NSF)
Measured: 12, 24 and 36 weeks
PANSS Positive Subscale Score
Change from Baseline in the PANSS Positive sub-scale score
Measured: 12, 24 and 36 weeks
PANSS Negative Subscale Score
Change from Baseline in the PANSS Negative sub-scale score
Measured: 12, 24 and 36 weeks
PANSS General Psychopathological Subscale Score
Change from Baseline in the PANSS General Psychopathological sub-scale score
Measured: 12, 24 and 36 weeks
BNSS (Brief Negative Symptom Scale) Score
Change from Baseline in the BNSS (Brief Negative Symptom Scale) score
Measured: 12, 24 and 36 weeks
BACS (Brief Cognitive Assessment in Schizophrenia) Score
Change from Baseline in the BACS (Brief Cognitive Assessment in Schizophrenia) score
Measured: 12, 24 and 36 weeks
Reported adverse events (descriptive)
Safety and tolerability assessment
Measured: From enrollment to the end of treatment at 36 weeks
Weight (kg)
Safety and tolerability assessment
Measured: From enrollment to the end of treatment at 36 weeks
Height (cm)
Safety and tolerability assessment
Measured: From enrollment to the end of treatment at 36 weeks
BMI (Body Mass Index, kg/cm^2)
Safety and tolerability assessment
Measured: From enrollment to the end of treatment at 36 weeks
Blood pressure (mm Hg)
Safety and tolerability assessment
Measured: From enrollment to the end of treatment at 36 weeks
Heart rate (BPM)
Safety and tolerability assessment
Measured: From enrollment to the end of treatment at 36 weeks
Electrocardiogram (ECG)
Safety and tolerability assessment
Measured: From enrollment to the end of treatment at 36 weeks
Complete Blood Count (CBC)
Safety and tolerability assessment
Measured: From enrollment to the end of treatment at 36 weeks
Serum creatinine
kidney function test, mg/dL, Safety and tolerability assessment
Measured: From enrollment to the end of treatment at 36 weeks
Serum alanine transaminase
ALT, liver function test, U/L, Safety and tolerability assessment
Measured: From enrollment to the end of treatment at 36 weeks
Serum ferritin
iron store index, ng/mL, Safety and tolerability assessment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 36 weeks
Quantitative MRI - R2*
R2* is influenced by magnetic field inhomogeneities and is sensitive to iron deposition and other sources
Measured: 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
Measured: 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)
Measured: 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
Measured: Baseline, 36 weeks
Quantitative MRI - Tissue Relaxivity (MTV Dependency)
Parameter-MTV slope (MDM: Multidimensional Dependency on MTV) reflects lipid and macromolecular composition
Measured: Baseline, 36 weeks
Quantitative MRI - Diffusion MRI
Mean Diffusivity (MD)
Measured: Baseline, 36 weeks
Quantitative MRI - Diffusion MRI
Fractional Anisotropy (FA)
Measured: 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
Measured: Baseline, 36 weeks
Quantitative MRI - Macroscopic Morphometry
Cortical volume
Measured: 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
Measured: Baseline, 36 weeks
Magnetic Resonance Spectroscopy (MRS)
Estimates concentrations of brain metabolites
Measured: Baseline, 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start12 Aug 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (78)Papers the sponsor has linked to this study.
- Other trials for Schizoaffecitve DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amit Lotan
- Sponsor type
- University, hospital or other
- Collaborators
- Hadassah Medical Organization, Jerusalem Mental Health Center, Hebrew University of Jerusalem
- Responsible party
- Sponsor-investigator, Amit Lotan, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759895
- Sponsor's protocol ID
- 0239-24-HMO
- Other IDs
- Israel Innovation Authority
- Acronym
- IronMan
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beebe LH, Smith K. Informed consent to research in persons with schizophrenia spectrum disorders. Nurs Ethics. 2010 Jul;17(4):425-34. doi: 10.1177/0969733010364581.
PubMed 20610576Janno S, Holi MM, Tuisku K, Wahlbeck K. Validity of Simpson-Angus Scale (SAS) in a naturalistic schizophrenia population. BMC Neurol. 2005 Mar 17;5(1):5. doi: 10.1186/1471-2377-5-5.
PubMed 15774006Blanchet PJ, Rompre PH. Clinimetric evaluation of the Simpson-Angus Scale in older adults with schizophrenia. J Clin Psychopharmacol. 2014 Feb;34(1):36-9. doi: 10.1097/JCP.0b013e3182a6a2e3.
PubMed 24145218Keefe RS, Harvey PD, Goldberg TE, Gold JM, Walker TM, Kennel C, Hawkins K. Norms and standardization of the Brief Assessment of Cognition in Schizophrenia (BACS). Schizophr Res. 2008 Jul;102(1-3):108-15. doi: 10.1016/j.schres.2008.03.024. Epub 2008 May 20.
PubMed 18495435Keefe RS, Goldberg TE, Harvey PD, Gold JM, Poe MP, Coughenour L. The Brief Assessment of Cognition in Schizophrenia: reliability, sensitivity, and comparison with a standard neurocognitive battery. Schizophr Res. 2004 Jun 1;68(2-3):283-97. doi: 10.1016/j.schres.2003.09.011.
PubMed 15099610Leucht S, Kane JM, Kissling W, Hamann J, Etschel E, Engel RR. What does the PANSS mean? Schizophr Res. 2005 Nov 15;79(2-3):231-8. doi: 10.1016/j.schres.2005.04.008. Epub 2005 Jun 27.
PubMed 15982856Breier A, Liffick E, Hummer TA, Vohs JL, Yang Z, Mehdiyoun NF, Visco AC, Metzler E, Zhang Y, Francis MM. Effects of 12-month, double-blind N-acetyl cysteine on symptoms, cognition and brain morphology in early phase schizophrenia spectrum disorders. Schizophr Res. 2018 Sep;199:395-402. doi: 10.1016/j.schres.2018.03.012. Epub 2018 Mar 24.
PubMed 29588126Betts MJ, Kirilina E, Otaduy MCG, Ivanov D, Acosta-Cabronero J, Callaghan MF, Lambert C, Cardenas-Blanco A, Pine K, Passamonti L, Loane C, Keuken MC, Trujillo P, Lusebrink F, Mattern H, Liu KY, Priovoulos N, Fliessbach K, Dahl MJ, Maass A, Madelung CF, Meder D, Ehrenberg AJ, Speck O, Weiskopf N, Dolan R, Inglis B, Tosun D, Morawski M, Zucca FA, Siebner HR, Mather M, Uludag K, Heinsen H, Poser BA, Howard R, Zecca L, Rowe JB, Grinberg LT, Jacobs HIL, Duzel E, Hammerer D. Locus coeruleus imaging as a biomarker for noradrenergic dysfunction in neurodegenerative diseases. Brain. 2019 Sep 1;142(9):2558-2571. doi: 10.1093/brain/awz193.
PubMed 31327002Desikan RS, Segonne F, Fischl B, Quinn BT, Dickerson BC, Blacker D, Buckner RL, Dale AM, Maguire RP, Hyman BT, Albert MS, Killiany RJ. An automated labeling system for subdividing the human cerebral cortex on MRI scans into gyral based regions of interest. Neuroimage. 2006 Jul 1;31(3):968-80. doi: 10.1016/j.neuroimage.2006.01.021. Epub 2006 Mar 10.
PubMed 16530430Klein A, Andersson J, Ardekani BA, Ashburner J, Avants B, Chiang MC, Christensen GE, Collins DL, Gee J, Hellier P, Song JH, Jenkinson M, Lepage C, Rueckert D, Thompson P, Vercauteren T, Woods RP, Mann JJ, Parsey RV. Evaluation of 14 nonlinear deformation algorithms applied to human brain MRI registration. Neuroimage. 2009 Jul 1;46(3):786-802. doi: 10.1016/j.neuroimage.2008.12.037. Epub 2009 Jan 13.
PubMed 19195496Sasaki M, Shibata E, Tohyama K, Takahashi J, Otsuka K, Tsuchiya K, Takahashi S, Ehara S, Terayama Y, Sakai A. Neuromelanin magnetic resonance imaging of locus ceruleus and substantia nigra in Parkinson's disease. Neuroreport. 2006 Jul 31;17(11):1215-8. doi: 10.1097/01.wnr.0000227984.84927.a7.
PubMed 16837857Shibata E, Sasaki M, Tohyama K, Kanbara Y, Otsuka K, Ehara S, Sakai A. Age-related changes in locus ceruleus on neuromelanin magnetic resonance imaging at 3 Tesla. Magn Reson Med Sci. 2006 Dec;5(4):197-200. doi: 10.2463/mrms.5.197.
PubMed 17332710Mullins PG, McGonigle DJ, O'Gorman RL, Puts NA, Vidyasagar R, Evans CJ; Cardiff Symposium on MRS of GABA; Edden RA. Current practice in the use of MEGA-PRESS spectroscopy for the detection of GABA. Neuroimage. 2014 Feb 1;86:43-52. doi: 10.1016/j.neuroimage.2012.12.004. Epub 2012 Dec 13.
PubMed 23246994Fischl B, Salat DH, Busa E, Albert M, Dieterich M, Haselgrove C, van der Kouwe A, Killiany R, Kennedy D, Klaveness S, Montillo A, Makris N, Rosen B, Dale AM. Whole brain segmentation: automated labeling of neuroanatomical structures in the human brain. Neuron. 2002 Jan 31;33(3):341-55. doi: 10.1016/s0896-6273(02)00569-x.
PubMed 11832223Stikov N, Campbell JS, Stroh T, Lavelee M, Frey S, Novek J, Nuara S, Ho MK, Bedell BJ, Dougherty RF, Leppert IR, Boudreau M, Narayanan S, Duval T, Cohen-Adad J, Picard PA, Gasecka A, Cote D, Pike GB. In vivo histology of the myelin g-ratio with magnetic resonance imaging. Neuroimage. 2015 Sep;118:397-405. doi: 10.1016/j.neuroimage.2015.05.023. Epub 2015 May 21.
PubMed 26004502