Investigating the neurobiology of schizophrenia across aging and disease progression
Aging and Disease Course: Contributions to Lifespan Neurobiology of Schizophrenia
This study looks at how schizophrenia affects the brain as people age and how the disease changes over time, comparing those with schizophrenia to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 168 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04951700 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the neurobiological aspects of schizophrenia (SZ) as they relate to aging and disease progression. By utilizing multimodal brain imaging and comprehensive cognitive assessments, the study will identify biomarkers that reflect changes in brain function and structure over time. Participants will include individuals diagnosed with schizophrenia and healthy controls, allowing for a comparative analysis of neurobiological markers. The findings may lead to the development of targeted interventions based on specific stages of the disease.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18-65 with a diagnosis of schizophrenia or schizoaffective disorder.
Not a fit: Patients with significant cognitive impairment or other neurological disorders that may affect brain function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of biomarkers that enable stage-dependent interventions for schizophrenia, potentially improving treatment outcomes.
How similar studies have performed: Other studies have shown promise in identifying neurobiological markers in schizophrenia, but this approach focusing on aging and disease course is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-65 years of age (SZ); 18-75 years of age (CON) * Women and men * All races and ethnicities * Psychiatric diagnoses: Patient participants (SZ): Meet DSM-5 criteria for schizophrenia or schizoaffective disorder Healthy control participants (CON): No personal history of lifetime psychiatric disorders, or a family history of psychotic disorders in 1st-or 2nd- degree relatives * Able to read, speak, and understand English * Able and willing to provide written informed consent; and willing to commit to the study protocol, including 2-year longitudinal follow-up Exclusion Criteria: • Compromised cognitive function: Both SZ and CON participants: Estimated premorbid intellectual ability \<75 age-corrected score on Wide Range Achievement Test-4/Word Reading Subtest (WRAT-4) CON participants: \<26 score on the Montreal Cognitive Assessment (MoCA) * Neurological or medical disorder that may affect brain function (history of stroke, head injury with a loss of consciousness \>10 min, seizure disorder, AIDS, poorly controlled hypertension, poorly controlled diabetes, decompensated lung disease, etc.) * Co-morbid DSM-5 diagnosis of drug/alcohol use disorder in prior 3 months * Current treatment with benzodiazepine or non-benzodiazepine sedatives/hypnotics, and/or anticonvulsants * Presence of ferromagnetic objects in body * Weight or body size exceeding MRI scanner capacity \[\>300 lbs\] * Claustrophobia in MRI scanner * Pregnant women * Breastfeeding women (VASO scan will not be administered. All other imaging modalities are safe to administer.) * Impaired kidney function: Glomerular Filtration Rate (GFR) \< 30 ml/min/1.73m2 (VASO scan will not be administered due to an association between Gadolinium-based MR contrast use and Nephrogenic Systemic Fibrosis in individuals with severely impaired renal function. All other imaging modalities are safe to administer.) * History of hypersensitivity to any MRI contrast agent (VASO scan will not be administered. All other imaging modalities are safe to administer.)
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Elena I. Ivleva, MD, PhD — UT Southwestern Medical Center, Department of Psychiatry
- Study coordinator: Elena I. Ivleva, MD, PhD
- Email: elena.ivleva@utsouthwestern.edu
- Phone: 214-645-8942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.