Schizophrenia Clinical Trial
Official title:
Brain Circuits in Schizophrenia and Smoking
Background:
- Smoking is associated with serious health risks. People who have mental illness are more
likely to smoke. Researchers are studying the brain circuits linked with smoking and nicotine
craving. This study will look at whether a specific brain circuit can explain the high rate
of smoking in people with schizophrenia.
Objectives:
- To study brain activity in smokers and nonsmokers with and without schizophrenia, as well
as their family members.
Eligibility:
- Current smokers (at least 100 cigarettes in the past year) and nonsmokers between 18 and
62 years of age in one of the following groups:
- Have been diagnosed with schizophrenia.
- Family members of those with schizophrenia.
- Healthy adults with no history of severe mental illness or brain trauma.
- Family members of the healthy adults.
Design:
- People in the study will be screened with a physical exam, medical history,
questionnaires, and blood tests.
- They will have up to three visits: the screening visit and two study visits (each given
1 year apart).
- At the first study visit, those taking part will be trained in the tests they will do
during the magnetic resonance imaging (MRI) scan. Then they will have the MRI scan.
- After the first study visit, current smokers will receive phone calls from the study
researchers every other month for 1 year. They will be asked about their smoking habits.
- At the second study visit, current smokers and some nonsmokers will have another MRI
scan and the same tests as before.
- Current smokers will receive a final phone call 1 year after the second study visit.
They will be asked to give information about their smoking habits.
Objective
The health risk associated with tobacco use is high, and is even higher in people with severe
mental illness. The underlying brain circuitry for smoking-mental illness comorbidity is
unknown. Identifying brain comorbidity circuitry is important for new therapeutic
development. This study will examine whether a specific brain circuitry can explain the high
rate of smoking in patients with schizophrenia. Identifying the key brain circuits associated
with smoking, especially smoking in a high risk population, will provide concrete biomarkers
for new therapeutic development, and ultimately reducing the smoking related health burden.
Study Population
Schizophrenic patients and their family members, non-schizophrenia controls and their family
members, including smokers and nonsmokers in each of the four groups will be included in this
study.
Design
1. A cross-sectional study for all subjects at baseline. They will receive clinical and
diagnostic interviews, functional, symptom, and cognitive testing, and MRI. They will
also have blood drawn, to identify brain circuits and covariates associated with the
severe smoking problem in schizophrenia.
2. A prospective longitudinal study design where smokers will be encouraged to quit smoking
and smoking cessation support is provided if needed, followed by retesting of imaging
and some clinical assessments, to identify brain circuits associated smoking cessation
or the difficulty of quitting in schizophrenia and non-schizophrenia smokers.
Outcome Measures
Combining event-related and resting fMRI techniques, we propose to test the hypothesis that
an abnormal dorsal anterior cingulate cortex (dACC) and ventral striatum (VS) circuit
underlies the high prevalence of comorbid smoking in schizophrenia. We also propose to test
specific clinical implications of this circuit including a within-subject event-related fMRI
study to test the mechanistic implication of the rsFC signals, a prospective follow-up to
test the circuit s predictive validity on smoking behavior change, and genetic studies to
describe the path from genes to brain circuits to smoking behaviors.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |