SchizophreniaNCT07108673
Value of Voxel-Based Morphometry in Schizophrenia
An observational study of Schizophrenia, run by Assiut University.
Trial summary
This cross-sectional observational study investigates structural brain abnormalities in schizophrenia and nicotine use disorder (NUD), with a focus on understanding how these abnormalities correlate with behavioral traits such as decision-making and impulsivity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- MRI
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2025to 20 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The targeted study groups are: Group 1: Schizophrenic patients without nicotine dependence. Group 2: Schizophrenic patients with nicotine dependence. Group 3: Nicotine use disorder individuals without schizophrenia. Each group will be matched for age, gender, and educational background to minimize potential confounding variables.
Who may be able to join
- Diagnosed schizophrenia (for groups 1 and 2).
- Nicotine dependence as defined by the Fagerström Test for Nicotine Dependence (for groups 2 and 3).
- Age range: 18-60 years.
- Schizophrenic patients must be stable on medications for at least 2 months.
- Written informed consent (from the patient or his carer).
Who cannot join
- History of other neurological or other psychiatric disorders (besides schizophrenia or nicotine dependence).
- Current substance use disorders other than nicotine.
- Severe head trauma or other conditions likely to affect brain structure.
- IQ below 70.
- MRI contraindications such as metallic implants (e.g. pace maker), claustrophobia or anxiety disorders severe enough to prevent comfortable MRI scanning will also be exclusion criteria.
About this study
Official title: Value of Voxel-Based Morphometry in Assessing Brain Structural Abnormalities in Schizophrenia and Nicotine Use Disorder.
This cross-sectional observational study investigates structural brain abnormalities in schizophrenia and nicotine use disorder (NUD), with a focus on understanding how these abnormalities correlate with behavioral traits such as decision-making and impulsivity. Schizophrenia is often associated with reduced gray matter (GM) in the prefrontal cortex and anterior cingulate cortex, while nicotine dependence is linked to changes in brain regions involved in reward processing. Nicotine use is particularly prevalent among individuals with schizophrenia, potentially compounding cognitive impairments.
Voxel-Based Morphometry (VBM), an advanced neuroimaging analysis technique, allows for the detection of subtle structural changes in the brain using MRI data. This study aims to utilize VBM to explore GM alterations in three participant groups:
Read more
Schizophrenic patients without nicotine dependence
Schizophrenic patients with nicotine dependence
Individuals with nicotine dependence but without schizophrenia
Each group will include 32 participants, making a total sample of 96, calculated using G*Power software assuming a medium effect size, alpha 0.05, and power 0.8. Inclusion criteria include confirmed diagnoses based on DSM-5 and the Fagerström Test for Nicotine Dependence, age 18-60, and MRI compatibility. Exclusion criteria involve other psychiatric or neurological disorders, substance use other than nicotine, and MRI contraindications.
Participants will undergo:
Structural MRI scans
Behavioral assessment using the Barratt Impulsiveness Scale
Clinical interviews using the Structured Clinical Interview for DSM-5
The primary outcome is to identify distinct patterns of GM reduction or alteration across groups, especially in regions involved in decision-making (e.g., prefrontal cortex, anterior cingulate cortex) and reward processing (e.g., ventral striatum). Secondary outcomes include correlating these structural findings with impulsivity and decision-making patterns.
Statistical analysis will be performed using SPSS v26. ANOVA will be used for quantitative comparisons across the three groups, while Chi-square or Fisher's exact tests will compare categorical variables. Pearson's correlation will be used to explore associations between brain changes and behavioral traits. A p-value <0.05 will be considered significant.
Read the detailed description
Schizophrenia and nicotine use disorder are two conditions linked in part to distinct brain structural abnormalities that can significantly impact cognitive and behavioral functions, particularly in areas like decision-making and impulsivity. Schizophrenia (although it's exact cause is unknown) is often associated with reduced gray matter (GM) in regions such as the prefrontal cortex and anterior cingulate cortex, which are crucial for cognitive control and decision-making processes . Nicotine use disorder, on the other hand, has been linked to structural changes in brain areas involved in reward processing and impulsivity regulation. The overlap of these conditions is notable, as nicotine addiction is highly prevalent among schizophrenic patients, potentially exacerbating cognitive and behavioral dysfunctions .
Voxel-Based Morphometry (VBM) is a widely used neuroimaging technique that enables researchers to detect and quantify brain structural differences, particularly in GM, by analyzing MRI scans. VBM allows for the identification of subtle brain abnormalities that may contribute to the development of schizophrenia and nicotine dependence. These structural changes may provide insight into associated behavioral traits such as impaired decision-making and increased impulsivity, both of which are commonly observed in individuals with either or both conditions
- Conditions
- Schizophrenia
- Being tested
- MRI
- Keywords
- Voxel-Based Morphometry, Brain Structural Abnormalities, Schizophrenia, Nicotine use disorder
- Medical subject headings
- Schizophrenia, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
structural MRI imaging and behavioral testing (e.g. Barratt Impulsiveness scale) both performed by skilled physicians.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenic patients without nicotine dependence | Not described Receives: Diagnostic Test: MRI | |
| Schizophrenic patients with nicotine dependence | Not described Receives: Diagnostic Test: MRI | |
| Individuals with nicotine dependence but without schizophrenia | Not described Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
structural abnormalities by MRI
we will catch any structural abnormalities like GM reductions in the prefrontal cortex and anterior cingulate cortex
Measured: at the enrollment
Secondary outcomes (1)
Behavioral testing
Behavioral testing is expected to reveal that GM abnormalities correlate with impaired decision-making and increased impulsivity. By using Fagerstrom Test for Nicotine Dependence (FTND): Classifies participants' nicotine addiction levels.
Structured Clinical Interview for DSM-5: Confirms diagnoses of schizophrenia and nicotine use disorder.
Measured: at the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion20 Aug 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Mohammed Abdel-Moty, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108673
- Sponsor's protocol ID
- NCTMRISCHIZ2025
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Du X, Choa FS, Chiappelli J, Bruce H, Kvarta M, Summerfelt A, Ma Y, Regenold WT, Walton K, Wittenberg GF, Hare S, Gao S, van der Vaart A, Zhao Z, Chen S, Kochunov P, Hong LE. Combining neuroimaging and brain stimulation to test alternative causal pathways for nicotine addiction in schizophrenia. Brain Stimul. 2024 Mar-Apr;17(2):324-332. doi: 10.1016/j.brs.2024.02.020. Epub 2024 Mar 5.
PubMed 38453003Wilke M, Kaufmann C, Grabner A, Putz B, Wetter TC, Auer DP. Gray matter-changes and correlates of disease severity in schizophrenia: a statistical parametric mapping study. Neuroimage. 2001 May;13(5):814-24. doi: 10.1006/nimg.2001.0751.
PubMed 11304078Liu H, Guan L, Nie Y, Li Q, Xue J, Yang Y, Rong S, Liang J, Guan Y, Zhai F, Ren Y, An Z, Dong Z, Han Z. Brain Magnetic Resonance Imaging Features of Nicotine-Dependent Individuals and Its Correlation with Polymorphisms of Dopamine D Receptor Gene. Contrast Media Mol Imaging. 2022 Aug 24;2022:2296776. doi: 10.1155/2022/2296776. eCollection 2022.
PubMed 36082055Brown GG, Lee JS, Strigo IA, Caligiuri MP, Meloy MJ, Lohr J. Voxel-based morphometry of patients with schizophrenia or bipolar I disorder: a matched control study. Psychiatry Res. 2011 Nov 30;194(2):149-56. doi: 10.1016/j.pscychresns.2011.05.005. Epub 2011 Sep 15.
PubMed 21924872Segall JM, Turner JA, van Erp TG, White T, Bockholt HJ, Gollub RL, Ho BC, Magnotta V, Jung RE, McCarley RW, Schulz SC, Lauriello J, Clark VP, Voyvodic JT, Diaz MT, Calhoun VD. Voxel-based morphometric multisite collaborative study on schizophrenia. Schizophr Bull. 2009 Jan;35(1):82-95. doi: 10.1093/schbul/sbn150. Epub 2008 Nov 7.
PubMed 18997157
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Voxel-Based Morphometry in Assessing Brain Structural Abnormalities in Schizophrenia and Nicotine Use Disorder.
- ClinicalTrials.gov ID
- NCT07108673
- Acronym / sponsor ID
- NCTMRISCHIZ2025
- Conditions
- Schizophrenia
- Keywords
- Voxel-Based Morphometry, Brain Structural Abnormalities, Schizophrenia, Nicotine use disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cross-sectional observational study investigates structural brain abnormalities in schizophrenia and nicotine use disorder (NUD), with a focus on understanding how these abnormalities correlate with behavioral traits such as decision-making and impulsivity. Schizophrenia is often associated with reduced gray matter (GM) in the prefrontal cortex and anterior cingulate cortex, while nicotine dependence is linked to changes in brain regions involved in reward processing. Nicotine use is particularly prevalent among individuals with schizophrenia, potentially compounding cognitive impairments.
Voxel-Based Morphometry (VBM), an advanced neuroimaging analysis technique, allows for the detection of subtle structural changes in the brain using MRI data. This study aims to utilize VBM to explore GM alterations in three participant groups:
Schizophrenic patients without nicotine dependence
Schizophrenic patients with nicotine dependence
Individuals with nicotine dependence but without schizophrenia
Each group will include 32 participants, making a total sample of 96, calculated using G*Power software assuming a medium effect size, alpha 0.05, and power 0.8. Inclusion criteria include confirmed diagnoses based on DSM-5 and the Fagerström Test for Nicotine Dependence, age 18-60, and MRI compatibility. Exclusion criteria involve other psychiatric or neurological disorders, substance use other than nicotine, and MRI contraindications.
Participants will undergo:
Structural MRI scans
Behavioral assessment using the Barratt Impulsiveness Scale
Clinical interviews using the Structured Clinical Interview for DSM-5
The primary outcome is to identify distinct patterns of GM reduction or alteration across groups, especially in regions involved in decision-making (e.g., prefrontal cortex, anterior cingulate cortex) and reward processing (e.g., ventral striatum). Secondary outcomes include correlating these structural findings with impulsivity and decision-making patterns.
Statistical analysis will be performed using SPSS v26. ANOVA will be used for quantitative comparisons across the three groups, while Chi-square or Fisher's exact tests will compare categorical variables. Pearson's correlation will be used to explore associations between brain changes and behavioral traits. A p-value <0.05 will be considered significant.
Detailed description
Schizophrenia and nicotine use disorder are two conditions linked in part to distinct brain structural abnormalities that can significantly impact cognitive and behavioral functions, particularly in areas like decision-making and impulsivity. Schizophrenia (although it's exact cause is unknown) is often associated with reduced gray matter (GM) in regions such as the prefrontal cortex and anterior cingulate cortex, which are crucial for cognitive control and decision-making processes . Nicotine use disorder, on the other hand, has been linked to structural changes in brain areas involved in reward processing and impulsivity regulation. The overlap of these conditions is notable, as nicotine addiction is highly prevalent among schizophrenic patients, potentially exacerbating cognitive and behavioral dysfunctions .
Voxel-Based Morphometry (VBM) is a widely used neuroimaging technique that enables researchers to detect and quantify brain structural differences, particularly in GM, by analyzing MRI scans. VBM allows for the identification of subtle brain abnormalities that may contribute to the development of schizophrenia and nicotine dependence. These structural changes may provide insight into associated behavioral traits such as impaired decision-making and increased impulsivity, both of which are commonly observed in individuals with either or both conditions
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Schizophrenic patients without nicotine dependence | – | Diagnostic Test: MRI |
| Schizophrenic patients with nicotine dependence | – | Diagnostic Test: MRI |
| Individuals with nicotine dependence but without schizophrenia | – | Diagnostic Test: MRI |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The targeted study groups are: Group 1: Schizophrenic patients without nicotine dependence. Group 2: Schizophrenic patients with nicotine dependence. Group 3: Nicotine use disorder individuals without schizophrenia. Each group will be matched for age, gender, and educational background to minimize potential confounding variables.
Key inclusion criteria (5 listed)
- Diagnosed schizophrenia (for groups 1 and 2).
- Nicotine dependence as defined by the Fagerström Test for Nicotine Dependence (for groups 2 and 3).
- Age range: 18-60 years.
- Schizophrenic patients must be stable on medications for at least 2 months.
- Written informed consent (from the patient or his carer).
Key exclusion criteria (5 listed)
- History of other neurological or other psychiatric disorders (besides schizophrenia or nicotine dependence).
- Current substance use disorders other than nicotine.
- Severe head trauma or other conditions likely to affect brain structure.
- IQ below 70.
- MRI contraindications such as metallic implants (e.g. pace maker), claustrophobia or anxiety disorders severe enough to prevent comfortable MRI scanning will also be exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIstructural MRI imaging and behavioral testing (e.g. Barratt Impulsiveness scale) both performed by skilled physicians. | Diagnostic test | Individuals with nicotine dependence but without schizophrenia, Schizophrenic patients with nicotine dependence, Schizophrenic patients without nicotine dependence |
Primary outcome
structural abnormalities by MRI
Time frame: at the enrollment
we will catch any structural abnormalities like GM reductions in the prefrontal cortex and anterior cingulate cortex
1 secondary outcome
Behavioral testing
Time frame: at the enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Background: PubMed 38453003Du X, Choa FS, Chiappelli J, Bruce H, Kvarta M, Summerfelt A, Ma Y, Regenold WT, Walton K, Wittenberg GF, Hare S, Gao S, van der Vaart A, Zhao Z, Chen S, Kochunov P, Hong LE. Combining neuroimaging and brain stimulation to test alternative causal pathways for nicotine addiction in schizophrenia. Brain Stimul. 2024 Mar-Apr;17(2):324-332. doi: 10.1016/j.brs.2024.02.020. Epub 2024 Mar 5.
- Background: PubMed 11304078Wilke M, Kaufmann C, Grabner A, Putz B, Wetter TC, Auer DP. Gray matter-changes and correlates of disease severity in schizophrenia: a statistical parametric mapping study. Neuroimage. 2001 May;13(5):814-24. doi: 10.1006/nimg.2001.0751.
- Background: PubMed 36082055Liu H, Guan L, Nie Y, Li Q, Xue J, Yang Y, Rong S, Liang J, Guan Y, Zhai F, Ren Y, An Z, Dong Z, Han Z. Brain Magnetic Resonance Imaging Features of Nicotine-Dependent Individuals and Its Correlation with Polymorphisms of Dopamine D Receptor Gene. Contrast Media Mol Imaging. 2022 Aug 24;2022:2296776. doi: 10.1155/2022/2296776. eCollection 2022.
- Background: PubMed 21924872Brown GG, Lee JS, Strigo IA, Caligiuri MP, Meloy MJ, Lohr J. Voxel-based morphometry of patients with schizophrenia or bipolar I disorder: a matched control study. Psychiatry Res. 2011 Nov 30;194(2):149-56. doi: 10.1016/j.pscychresns.2011.05.005. Epub 2011 Sep 15.
- Background: PubMed 18997157Segall JM, Turner JA, van Erp TG, White T, Bockholt HJ, Gollub RL, Ho BC, Magnotta V, Jung RE, McCarley RW, Schulz SC, Lauriello J, Clark VP, Voyvodic JT, Diaz MT, Calhoun VD. Voxel-based morphometric multisite collaborative study on schizophrenia. Schizophr Bull. 2009 Jan;35(1):82-95. doi: 10.1093/schbul/sbn150. Epub 2008 Nov 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
structural abnormalities by MRI (time frame: at the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07108673, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.