Adults 18 to 50, any sex, with Schizophrenia or Schizophrenia Schizoaffective. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Auditory Hallucinations Rating Scale (AHRS) Score From BaselineSecondary· Baseline, Final Study Visit (Day 14-16)
A 7-item scale developed to measure specific characteristics of auditory hallucinations (frequency, reality, loudness, number of voices, length, attentional salience, distress level). Each item is rated on a separate Likert scale. The total score, ranging from 0 to 44, indicates the overall severity of the hallucinations, with higher scores suggesting more severe symptoms.
Group
Value
95% CI
PLIFUS
-1.4
± 2.4
Sham
-1
± 1.9
Change in Delusions Experience Sampling Assessment (DESA) Score From BaselineSecondary· Baseline, Final Study Visit (Day 14-16)
A 4-item scale (conviction, distress, preoccupation, disruption) used to assess moment-to-moment experience and detect more rapid changes of delusions. Participants are asked to rate the same delusional belief at the moment on a 7-point Likert scale (1 (not at all) to 7 (very much)). The total score is the sum of responses ranging from 1-28; higher scores indicate more severe symptoms.
Group
Value
95% CI
PLIFUS
-1
± 3.4
Sham
0.3
± 2.9
Adverse events — posted to ClinicalTrials.gov
Time frame: AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a single-site, phase 2, sham-controlled random-order cross-over pilot trial of PLIFUS targeting the right GPi in individuals with schizophrenia. Twelve individuals with schizophrenia who report continuous hallucinations or delusions of mild or greater severity will receive one session of PLIFUS and one session of sham PLIFUS in random order, one week apart. If no effect of PLIFUS is detected on measures of functional connectivity or psychotic symptoms in the first four completers, the trial will be changed to 3 sessions of PLIFUS or sham administered over 5 days.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
Last refreshed: 30 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05643196.