NCT07593456Not yet recruiting
NST-SPARK Open-Label Phase 1 STTR (IGNITE)
Investigating a Gamified NegatIve-symptom Therapeutic Based on Evidence-based Cognitive Therapy (IGNITE)
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 5 May 2026
- Start date
- Mar 2027
- Primary completion date
- Feb 2028
- Lead sponsor
- North Shore Therapeutics, Inc.
- Diseases
- Schizophrenia
- NCT number
- NCT07593456
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Mar 2027 to the primary completion date, Feb 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has previously undergone cognitive behavioral therapy for psychosis or recovery-oriented cognitive therapy for negative symptoms.
Other illness
- Cognitive impairment limiting engagement in study
Other
- 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
- Prominent mood symptoms as defined by active manic, hypomanic or depressive episode.
Who the study is looking for
- 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).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zucker Hillside Hospital Coordinator of this site? Confirm its status | Glen Oaks | United States | Unknown status |
| Perelman School of Medicine Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.