Adults 18 to 65, any sex, with Schizophrenia or Schizoaffective Disorder. 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.
Timeline Follow Back (TLFB)Primary· 12 weeks
The Timeline Follow Back (TLFB) scale is used to measure weekly substance use for alcohol, marijuana, cocaine, and/or heroin by assessing the number of days a person used substances in the past week, on a scale from 0 to 7 \[0 = no substances that week; 7 = substance use every day\]. The outcome measure was the number of days per week that participants used a substance. If participants use more than one substance, only the primary substance (one used mostly frequently) was analyzed.
While the TLFB was assessed weekly, the outcome measure reported is the change in substance use between Week 0
Group
Value
95% CI
Experimental
-1.765
-3.117 – -.413
Treatment as Usual
-.532
-1.910 – .846
Visual Analog Scale (VAS)Primary· 12 weeks
The Visual Analog Scale (VAS) measures substance craving. Subjects will make a mark on an unlabeled 100-millimeter line indicating their desire to use a particular substance over the past 7-days. A score of 0 indicates no desire to use and 100 indicating the strongest desire to use possible. The assessment was done weekly. Subjects reported craving for any substances they used that week with a separate mark for each substance (e.g., a mark for alcohol craving and another mark for marijuana). For outcome measures, only the primary substance (the substance used most frequently, as determined by
Group
Value
95% CI
Experimental
-33.421
-49.305 – -17.536
Treatment as Usual
-8.898
-25.511 – 7.716
Amount of Money Spent on SubstancesSecondary· 12 weeks
The amount of money spent on substances over a 7-day period will also be recorded as part of each weekly visit. Decreased money spent on substances over a 7-day period will also be considered an improved outcome.
Group
Value
95% CI
Experimental
-20.974
-51.647 – 9.700
Treatment as Usual
14.605
-16.497 – 45.707
Positive and Negative Symptom Scale (PANSS)Secondary· 12 Weeks
The Positive and Negative Symptom Scale (PANSS) is a measure used to assess symptom severity in patients with schizophrenia. Each item (symptom) is scored on a 7-point scale (1 = absent and 7 = extreme). The minimum and maximum values for the total 30 items (PANSS Total Score) are 30 and 210 respectively. Higher scores represent higher levels of psychiatric symptoms (worse outcomes).
The PANSS has three subscales: "Positive" (measuring positive symptoms), "Negative" (measuring negative symptoms), and "General Psychopathology" (measuring general psychiatric symptoms). There are 7 items each fo
Group
Value
95% CI
Experimental
-3.690
-9.188 – 1.807
Treatment as Usual
-.274
-5.996 – 5.447
Clinical Global Impression - SeveritySecondary· 12 Weeks
The Clinical Global Impression - Severity (CGI-S) measures illness severity on a 7-point Likert scale, with a higher score indicating higher illness severity and worse outcomes (1 = "Normal, not at all ill" and 7 = "Among the most extremely ill patients"). The outcome measure for this study looked at the change in the CGI-S score between Week 0 (Baseline) and Week 12 (end of study), with a reduction in score indicating improved outcomes.
Group
Value
95% CI
Experimental
-.320
-.601 – -.038
Treatment as Usual
-.128
-.413 – .156
Heinrichs Carpenter Quality of Life Scale (QOL)Secondary· 12 Weeks
The Heinrichs Carpenter Quality of Life Scale (QOL)is a 21-item scale providing information on symptoms and functioning in patients with schizophrenia. Items are scored on a 0-6 scale, with 0 being no evidence of that item (e.g., social relationships are virtually absent) and 6 being adequate evidence of that item (e.g., adequate social relationships). Two items (#1 - "Intimate relationship with household members" and # 12 - "Satisfaction with occupational role functioning") are scored a "9" if the item is not applicable (e.g., lives alone with no close family or does not have an occupational
Group
Value
95% CI
Experimental
4.049
-1.950 – 10.049
Treatment as Usual
-5.146
-11.293 – 1.001
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected from each participant's screening through their study completion (Week 12 or Early Termination), an average of 3 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The proposed study is a 4-site, 12-week, novel, feasibility, investigation of patients who have co-occurring diagnoses of schizophrenia and current substance use disorder (alcohol, cocaine, heroin, or cannabis). Thirty-nine participants will be randomly assigned to switch to brexpiprazole (the brexpiprazole group) or remain on the same antipsychotic treatment (the control group). The study will be conducted at 4 sites in the US. The investigators expect to enroll 80 subjects across 3 sites. UMass Medical School, Worcester MA is the lead site. Sub-sites include Massachusetts General Hospital (MGH) and the University of North Carolina at Chapel Hill (UNC).
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05962216 — Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders
· recruiting
NCT05017311 — Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)
· Phase 4
· recruiting
NCT05504486 — Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety
· Phase 4
· withdrawn
NCT05169268 — Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia
· recruiting
NCT04830215 — Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder
· Phase 4
· completed
Other recruiting trials for Schizophrenia
Currently open trials in the same condition.
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Other University of Massachusetts, Worcester trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Massachusetts, Worcester
Last refreshed: 23 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/NCT03526354.