Phase 2
N=28
Pharmacologic Augmentation of Targeted Cognitive Training in Schizophrenia
Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04414930 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Primary Clinical Outcome PANSS Total Score (PANSSt) — 65.4; 55.6; 67.1; 49.8 score on a scale — p=0.28
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- d-amphetamine (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Clinical Outcome PANSS Total Score (PANSSt) |
65.4; 55.6; 67.1; 49.8; 61.0; 50.5 | 0.28 |
| PRIMARY Primary Functional Outcome WHODAS |
26.6; 53.1; 38.1; 43.7; 29.6; 34.5 | 0.05 |
| PRIMARY Primary Neurocognitive Outcome MCCB-C |
17.7; 29.8; 19.3; 30.4; 21.3; 34.3 | 0.93 |
| SECONDARY Secondary Clinical Outcome Measure PANSSp |
16.6; 15.2; 16.6; 12.5; 16.0; 13.9 | 0.43 |
| SECONDARY Secondary Clinical Outcome Measure PANSSn |
16.6; 12.8; 17.4; 12.9; 15.9; 12.1 | 0.77 |
| SECONDARY Psychotic Symptoms PSYRATS Hallucinations |
2.7; 16.3; 3.4; 11.3; 5.6; 13.9 | 0.50 |
| SECONDARY Manic Symptoms YMRS |
7.0; 5.6; 6.0; 2.6; 5.9; 3.3 | 0.636 |
| SECONDARY Current Depressive Symptoms PHQ |
4.4; 6.3; 6.3; 2.9; 4.0; 4.4 | 0.19 |
Summary
These studies look to conduct efficient pilot testing of a novel intervention strategy for chronic psychotic disorders - Pharmacologic Augmentation of Cognitive Therapy (PACT) - via an experimental medicine approach. Antipsychotics are the major therapeutic tool for chronic psychotic disorders, including schizophrenia, but do not significantly alter their course or real-life impact. Specific cognitive therapies achieve modest symptom reduction and improved function and cognition in psychosis patients, including "bottom-up" sensory-based targeted cognitive training (TCT). While benefits of TCT are evident at the group level, almost half of all patients demonstrate little or no cognitive gains after 30-40 hours (h) of TCT. For patients and clinicians, the costs and logistical complexities associated with these time- and resource-intensive interventions can be prohibitive. We propose and will test a novel "augmentation strategy" for using medications to specifically enhance the benefits of TCT in schizophrenia.
Eligibility Criteria
Inclusion criteria include:
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder, depressed type
- Written informed consent to participate in the study
- Age 18 - 55
- Absence of dementia or mental retardation
- Urine toxicology negative for recreational drugs
- Fluent and literate in English (needed for completion of WIN and QuickSIN)
Exclusion criteria include:
- Meets DSM-IV criteria for current substance abuse or dependence and has been substance abstinent for less than 30 days
- A history of traumatic brain injury
- Auditory or visual impairments severe enough to prevent study participation
- Under conservatorship (determined by Anasazi)
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT04414930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.