Status:

RECRUITING

tVNS, Motivation, and Insulin Sensitivity

Lead Sponsor:

University of Bonn

Conditions:

Major Depressive Disorder (MDD)

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief Summary

Disturbances in energy metabolism significantly increase the risk of developing major depressive disorder (MDD), especially in individuals with type 2 diabetes. Insulin sensitivity may particularly im...

Detailed Description

To assess where individual reward deficits manifest, participants will undergo an intake session that includes clinical interviews, a fasting blood draw, and a battery of reward tasks (Reward Rating, ...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Participants with depression (DSM-5 diagnosis) or participants without depression (no DSM-5 diagnosis, lifetime)
  • BMI between 18.5 and 40 kg/m²
  • Age between 18 and 60 years
  • Legally valid informed consent
  • Exclusion criteria:
  • The following diagnoses in medical history:
  • Brain injury
  • Schizophrenia
  • Bipolar disorder
  • Severe substance use disorder
  • Coronary heart disease
  • Stroke
  • Epilepsy
  • Chronic inflammatory diseases (e.g., rheumatoid arthritis, Crohn's disease, etc.)
  • Type I diabetes
  • The following diagnoses within 12 months prior to the experiment:
  • Obsessive-compulsive disorder
  • Somatic symptom disorder
  • Eating disorder
  • The following diagnoses in medical history for control participants:
  • Depression
  • Anxiety disorders (except specific phobias)
  • Generally:
  • Contraindications for MRI (e.g., metal implants, claustrophobia) or taVNS (e.g., piercings, sore or diseased skin on the outer right ear)
  • Pregnant and breastfeeding women will not be included
  • Unclear capacity to consent
  • Stomach surgeries affecting body weight (e.g., bypass surgeries)

Exclusion

    Key Trial Info

    Start Date :

    October 10 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2027

    Estimated Enrollment :

    120 Patients enrolled

    Trial Details

    Trial ID

    NCT07198100

    Start Date

    October 10 2025

    End Date

    December 1 2027

    Last Update

    December 24 2025

    Active Locations (1)

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    1

    Section of Medical Psychology, Department of Psychiatry & Psychotherapy, Faculty of Medicine, University of Bonn

    Bonn, Germany, 53127