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NCT07910318Toborzás még nem indult

Neurostructural and Biochemical Signatures of Tobacco Smoking in Mood Disorders

Neurostructural and Biochemical Signatures of Tobacco Smoking in Mood Disorders: A Case-Control Study

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 2.

Rövid összefoglaló (regiszter, angolul)

Tobacco smoking is significantly more common among individuals with mood disorders, such as major depressive disorder (MDD) and bipolar disorder, compared to the general population. Chronic smoking in these conditions is often linked to more severe symptoms, frequent episodes, and reduced overall quality of life. However, the biological mechanisms linking tobacco smoking to brain alterations and clinical outcomes in mood disorders remain incompletely understood. The primary purpose of this study is to examine whether chronic tobacco cigarette smoking is associated with alterations in brain structure, specifically regional brain volumes including the hippocampus and insula, and circulating biochemical markers of neuronal injury (neurofilament light chain \[NfL\]) and neurobiological pathways (tryptophan and kynurenic acid). The study will enroll 240 male participants aged 18 to 45 years across six equal groups: 1. Major depressive disorder (in remission) who are current smokers 2. Major depressive disorder (in remission) who are lifetime never-smokers 3. Bipolar disorder who are current smokers 4. Bipolar disorder (in remission) who are lifetime never-smokers 5. Healthy controls who are current smokers 6. Healthy controls who are lifetime never-smokers Participants will take part in a single study visit involving: * Clinical assessments and psychiatric rating scales evaluating mood symptoms, cognition, personality traits, and smoking history. * Routine physical and vital sign measurements. * A fasting morning blood draw to evaluate serum biomarkers (NfL, tryptophan, kynurenic acid) and confirm tobacco exposure via serum cotinine. * A structural brain magnetic resonance imaging (MRI) scan to measure regional brain volumes.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Megfigyeléses
Résztvevők száma
240 (tervezett)
Első benyújtás
2026. okt. 27.
Kezdés
2026. nov.
Elsődleges befejezés
2027. nov.
Fő szponzor
Assiut University
NCT-szám
NCT07910318

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Tervezett résztvevők: 240
  • 2026. nov. és az elsődleges befejezés (2027. nov.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Treatment with electroconvulsive therapy (ECT) within the preceding 6 months.

Más betegség

  • Pre-existing neurological disorders or psychiatric disorders other than the target mood disorder.
  • Any current substance use disorder other than tobacco (caffeine use is permitted).
  • Standard contraindications to magnetic resonance imaging (MRI), including cardiac pacemakers, ferromagnetic or metallic orthopedic implants, severe claustrophobia, or inability to remain still during scanning.

Egyéb

  • Intellectual disability (IQ \< 70).

Kiket keres a vizsgálat

  • Male sex, aged 18 to 45 years.
  • Belongs to one of the target diagnostic categories:
    • Major Depressive Disorder (currently in clinical remission).
    • Bipolar Disorder (in clinical remission/euthymic or manic/hypomanic).
    • Healthy control with no personal history of psychiatric or neurological disorders (frequency-matched on age and education).
  • Smoking exposure status meeting one of the predefined criteria:
    • Current active, chronic tobacco cigarette smoker.
    • Lifetime never-smoker.
  • Capable of providing written informed consent and undergoing study assessments.

Életkor a regiszterben: 18 év – 45 év · Nem: csak férfiak

A teljes feltétellista: ClinicalTrials.gov

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