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Effects of Ghrelin Administration on Motivation

NCT ID: NCT06576440

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-02

Study Completion Date

2024-12-20

Brief Summary

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Everyday humans are confronted with a plethora of rewards competing for their attention. Nevertheless, to obtain a goal or reward, humans often need to invest effort. When humans are confronted with the challenge to integrate costs of action such as the effort of walking to one's favorite lunch place with its anticipated benefits (i.e., eating one's favorite meal), accumulating evidence suggest that humans might "go with the gut". Ghrelin is a stomach-derived hormone and the only known circulating peptide that stimulates appetite. At the same time, patients with major depressive disorder report deficits in motivated behavior which are oftentimes accompanied by changes in appetite and weight. Based on a wealth of accruing evidence from animal studies, the investigators suggest that the gut acts as an important arbitrator in effort allocation by signaling the energy level of the body. Within this physiological framework, ghrelin is thought to signal a short-term energy deficit to increase reward responsivity and willingness to work for reward as compensatory (allostatic) means. Here, the investigators propose to conduct a follow-up study (to NCT05318924) with subcutaneous administration of ghrelin vs. saline in patients with major depressive disorder and healthy control participants. During each visit, participants will receive a subcutaneous administration of either ghrelin or saline and perform an effort allocation task where they have to exert physical effort to obtain food and monetary rewards. The investigators hypothesize that ghrelin will increase the motivation to exert effort for rewards. The goal of this follow-up study is to test that the motivational effects of ghrelin are similar in patients with depression and healthy control participants. Furthermore, participants resting energy expenditure will be estimated before and after the administration. In line with a role of ghrelin as an energy deficit signal, the investigators expect ghrelin to decrease energy expenditure. During each visit, participants will answer questions about their current mood and physiological state. The investigators hypothesize that ghrelin increases mood state and hunger while decreasing satiety.

Detailed Description

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Conditions

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Major Depressive Disorder

Keywords

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energy homeostasis motivation ghrelin anhedonia mood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Major depressive disorder

Patients with major depressive disorder will receive a subcutaneous injection of ghrelin (experimental) on one day and saline (placebo) on another day (order randomised; double-blind cross-over design).

Group Type EXPERIMENTAL

Ghrelin

Intervention Type DRUG

Participants in this arm will receive a subcutaneous injection of acyl-ghrelin as the active condition.

Saline

Intervention Type DRUG

Participants in this arm will receive a subcutaneous injection of saline as placebo control condition.

Healthy control participants

Healthy control participants will receive a subcutaneous injection of ghrelin (experimental) on one day and saline (placebo) on another day (order randomised; double-blind cross-over design).

Group Type EXPERIMENTAL

Ghrelin

Intervention Type DRUG

Participants in this arm will receive a subcutaneous injection of acyl-ghrelin as the active condition.

Saline

Intervention Type DRUG

Participants in this arm will receive a subcutaneous injection of saline as placebo control condition.

Interventions

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Ghrelin

Participants in this arm will receive a subcutaneous injection of acyl-ghrelin as the active condition.

Intervention Type DRUG

Saline

Participants in this arm will receive a subcutaneous injection of saline as placebo control condition.

Intervention Type DRUG

Other Intervention Names

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Acyl-ghrelin Placebo

Eligibility Criteria

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Inclusion Criteria

\* Must have participated in the behavioral study arm of NCT05120336

Exclusion Criteria

* participation in the neuroimaging part of NCT05120336
* breastfeeding
* pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nils B Kroemer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tübingen, Faculty of Medicine, Department of Psychiatry & Psychotherapy

Locations

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Department of Psychiatry & Psychotherapy, University of Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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TUE008_ADMIN

Identifier Type: -

Identifier Source: org_study_id