NCT07108673Not yet recruiting
Value of Voxel-Based Morphometry in Schizophrenia
Value of Voxel-Based Morphometry in Assessing Brain Structural Abnormalities in Schizophrenia and Nicotine Use Disorder.
Source: ClinicalTrials.gov · Last updated 7 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 96 (estimated)
- First submitted
- 31 Jul 2025
- Start date
- 20 Aug 2025
- Primary completion date
- 20 Aug 2026
- Lead sponsor
- Assiut University
- Diseases
- Schizophrenia
- NCT number
- NCT07108673
What you commit to
- Study type: Observational
- Planned participants: 96
- From 20 Aug 2025 to the primary completion date, 20 Aug 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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.
Other
- IQ below 70.
Who the study is looking for
- 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).
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.