NST-SPARK Open-Label Phase 1 STTR (IGNITE)

Starting soon · Not applicable

Conditions studied: Schizophrenia / Schizoaffective Disorder

In brief

Schizophrenia Spectrum disorders (SSD) are among the most devastating psychiatric disorders. Prominent negative symptoms such as low motivation, anhedonia, asociality, and emotional flattening are experienced by up to 60% of individuals with SSD and are often considered to be the greatest contributors to functional disability. Currently, there are no FDA-approved or cleared medications or therapeutics targeting negative symptoms of schizophrenia. In this phase I proposal, North Shore Therapeutics (NST) is collaborating with the Feinstein Institutes of Medical Research (FIMR; Northwell Health) and the University of Pennsylvania (Penn) to develop a novel augmented reality (AR) therapeutic (NST-SPARK) targeting negative symptoms in individuals with SSD. NST-SPARK is a smartphone application that delivers Recovery-oriented Cognitive Therapy (CT-R) via gamified AR experiences to provide experiential learning that dismantles maladaptive beliefs. Preliminary findings suggest that this approach is feasible, acceptable, and may reduce defeatist beliefs associated with negative symptoms. NST-SPARK v.2.0 is being developed in partnership with a lived experience advisory panel. NST-SPARK v2.0 will deliver a 12-week course of treatment and will be developed over 10 development sprints spanning 9 months. In the second phase, the investigators will introduce NST-SPARK v2.0 to individuals with SSD (n=30) and moderate to severe negative symptoms for 12 weeks in a single-arm open-label study. The primary outcome is the efficacy of NST-SPARK v.2.0 in reducing experiential negative symptoms. Secondary outcomes include efficacy in reducing defeatist beliefs; efficacy in improving functioning; user statistics quantifying adherence to the prescribed sessions; qualitative, semi-structured feedback to guide future product development. This study will set the stage for FDA-informed phase II trials.

Key facts

Study ID: NCT07593456
Run by: North Shore Therapeutics, Inc.
People needed: 30
Starts: 2027-03-01
Expected to finish: 2028-08-31
Last updated by the study team: 2026-05-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 18-65 years
Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder or unspecified psychotic disorder
Clinically stable, defined as no acute positive psychotic symptom exacerbation or recent hospitalization or medication changes within the last month.
Moderate to severe negative symptoms: CAINS MAP subscale >17 (28).
Sufficient functioning and capacity to consent and participate in a longitudinal study.
Actively engaged in outpatient treatment.
Able and willing to use a smartphone and maintain internet connection during use (through wifi or data plan).

You may not qualify if…

Safety risk (e.g., suicide attempt or homicidal ideation within 12 weeks)
Issues that prevent subject from using the smartphone app: e.g., hearing, vision, or other relevant physical disability
IQ < 70 based on clinical and historical information
Cognitive impairment limiting engagement in study
Prominent mood symptoms as defined by active manic, hypomanic or depressive episode.
Has previously undergone cognitive behavioral therapy for psychosis or recovery-oriented cognitive therapy for negative symptoms.

Where it is running

Zucker Hillside Hospital — Glen Oaks, New York, United States
Perelman School of Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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