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Insulin resistance in brain reward pathways - the missing link between diabetes and depression

Insulin resistance in brain reward pathways - the missing link between diabetes and depression - PRIME-REWARD

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00024801
Enrollment
120
Registered
2023-05-24
Start date
2022-04-26
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F32 R73

Interventions

Group 1: A functional magnetic resonance imaging (fMRI) is conducted on the subjects following intranasal insulin administration, both during rest and while performing a reward task and an emotional s

Sponsors

Neurometabolic circuitry Lab Department for Psychiatry, Psychosomatics and Psychotherapy Goethe University Frankfurt
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for controls: • Age:18-65 years • Ability to give consent Inclusion criteria for diabetic patients: • Age:18-65 years • Presence of a prediabetic or diabetic condition according to the American Diabetes Association (American Diabetes, 2020): • Ability to give informed consent - only Metformin as medication allowed Inclusion criteria for depressive patients: • Age:18-65 years • Presence of a depressive Episode, both first episode or an an episode in the context of a know recurrent depressive disorder with or without psychotic symptoms (according to ICD 10: F32.0, F32.1, F32.2, F32.3, F33.2, F33.3). • Ability to give consent

Exclusion criteria

Exclusion criteria: Exclusion criteria for controls: • History of - Diabetes mellitus or prediabetic condition - Psychiatric diseases - neurological, autoimmune, rheumatological, neoplastic, dermatological or metabolic disorders - acute infection • Pregnancy and lactation • Regular medication with insulin, insulin-mimetika, antitiabetic drugs • Weight loss > 5 % of body weight within the last three months Exclusion criteria for patients: • History of - psychiatric disease: dementia, bipolar disorder, schizophrenic psychosis, substance abuse disorder - neurological, autoimmune, rheumatological, neoplastic, dermatological or other metabolic disorders than diabetes mellitus or prediabetes - skin disseases - acute infection • Medication with insulin/insulin-mimetika or glucocorticoids • Clearly organic or substance-induced cause of depression • Pregnancy and nursing • Weight loss > 5 % of body weight within the last three months

Design outcomes

Primary

MeasureTime frame
The change in fMRI brain activity during the performance of the reward task and the emotional stimulus processing task, following intranasal insulin administration, is investigated in depressed patients and patients with insulin resistance, compared to the activity after intranasal placebo administration, in comparison to the control group.

Secondary

MeasureTime frame
The alteration in reward learning and stress perception is investigated in depressed patients and patients with insulin resistance, compared to control subjects.

Countries

Germany

Contacts

Public ContactSharmili Edwin Thanarajah

Neurometabolic circuitry Lab Department for Psychiatry, Psychosomatics and Psychotherapy Goethe University Frankfurt

Sharmili.EdwinThanarajah@kgu.de+49 (0)69 6301 83356

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026