Major Depressive DisorderNCT06576440
Effects of Ghrelin Administration on Motivation
A study testing Ghrelin and Saline in people with Major Depressive Disorder, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Ghrelin and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 2 Sep 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have participated in the behavioral study arm of NCT05120336
Who cannot join
- participation in the neuroimaging part of NCT05120336
- breastfeeding
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry & Psychotherapy, University of Tübingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: The Effects of Ghrelin Administration on Motivation and Resting Energy Expenditure
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Ghrelin, Saline
- Keywords
- energy homeostasis, motivation, ghrelin, anhedonia, mood
- Medical subject headings
- Depressive Disorder, Major, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GhrelinDrug
Also called Acyl-ghrelin
Participants in this arm will receive a subcutaneous injection of acyl-ghrelin as the active condition.
SalineDrug
Also called Placebo
Participants in this arm will receive a subcutaneous injection of saline as placebo control condition.
| Study group | Role | What they receive |
|---|---|---|
| Major depressive disorder | Experimental | 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). Receives: Drug: Ghrelin; Drug: Saline |
| Healthy control participants | Experimental | 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). Receives: Drug: Ghrelin; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ghrelin-induced changes in motivation
Frequency of button presses on a XBox controller to obtain rewards after ghrelin administration vs. saline administration
Measured: 15-50 minutes after subcutaneous administration (ghrelin vs. saline)
Ghrelin-induced changes in Resting Energy Expenditure
Changes in energy expenditure after a ghrelin administration (vs. saline) as measured with indirect Calorimetry.
Measured: Pre injection versus 50-65 minutes after injection (compared to saline)
Ghrelin-induced changes in mood
Changes operationalized via visual analogue ratings (0-100) of the sum score of positive and negative affect schedule mood items after ghrelin administration vs. saline administration. Measures are taken ~40 minutes and 5 minutes prior to injection, as well as 15, 50, and 65 minutes after injection.
Measured: Pre injection timepoints (mean over 40 minutes and 5 minutes before) versus post injection timepoints (mean over 15, 50 and 65 minutes after injection) (compared to saline)
Ghrelin-induced changes in hunger and satiety from baseline
Change in visual analogue scale (0-100) measures of subjective hunger and satiety after ghrelin administration vs. saline administration. Measures are taken ~40 minutes and 5 minutes prior to injection, as well as 15, 50, and 65 minutes after injection.
Measured: Pre injection timepoints (mean over 40 minutes and 5 minutes before) versus post injection timepoints (mean over 15, 50 and 65 minutes after injection) (compared to saline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start2 Sep 2024
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nils B Kroemer, PhD, Principal investigator, University of Tübingen, Faculty of Medicine, Department of Psychiatry & Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576440
- Sponsor's protocol ID
- TUE008_ADMIN
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the publication of the key results of the study, behavioral data will be shared after aggregation at the trial or participant level.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ghrelin Administration on Motivation and Resting Energy Expenditure
- ClinicalTrials.gov ID
- NCT06576440
- Acronym / sponsor ID
- TUE008_ADMIN
- Conditions
- Major Depressive Disorder
- Keywords
- energy homeostasis, motivation, ghrelin, anhedonia, mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major depressive disorder | Experimental | Drug: Ghrelin, Drug: SalinePatients 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). |
| Healthy control participants | Experimental | Drug: Ghrelin, Drug: SalineHealthy 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). |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Must have participated in the behavioral study arm of NCT05120336
Key exclusion criteria (3 listed)
- participation in the neuroimaging part of NCT05120336
- breastfeeding
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GhrelinAlso: Acyl-ghrelinParticipants in this arm will receive a subcutaneous injection of acyl-ghrelin as the active condition. | Drug | Healthy control participants, Major depressive disorder |
| SalineAlso: PlaceboParticipants in this arm will receive a subcutaneous injection of saline as placebo control condition. | Drug | Healthy control participants, Major depressive disorder |
Primary outcome
Ghrelin-induced changes in motivation
Time frame: 15-50 minutes after subcutaneous administration (ghrelin vs. saline)
Frequency of button presses on a XBox controller to obtain rewards after ghrelin administration vs. saline administration
Ghrelin-induced changes in Resting Energy Expenditure
Time frame: Pre injection versus 50-65 minutes after injection (compared to saline)
Changes in energy expenditure after a ghrelin administration (vs. saline) as measured with indirect Calorimetry.
Ghrelin-induced changes in mood
Time frame: Pre injection timepoints (mean over 40 minutes and 5 minutes before) versus post injection timepoints (mean over 15, 50 and 65 minutes after injection) (compared to saline)
Changes operationalized via visual analogue ratings (0-100) of the sum score of positive and negative affect schedule mood items after ghrelin administration vs. saline administration. Measures are taken ~40 minutes and 5 minutes prior to injection, as well as 15, 50, and 65 minutes after injection.
Ghrelin-induced changes in hunger and satiety from baseline
Time frame: Pre injection timepoints (mean over 40 minutes and 5 minutes before) versus post injection timepoints (mean over 15, 50 and 65 minutes after injection) (compared to saline)
Change in visual analogue scale (0-100) measures of subjective hunger and satiety after ghrelin administration vs. saline administration. Measures are taken ~40 minutes and 5 minutes prior to injection, as well as 15, 50, and 65 minutes after injection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Yes. After the publication of the key results of the study, behavioral data will be shared after aggregation at the trial or participant level.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nils B Kroemer, PhD principal investigator
University of Tübingen, Faculty of Medicine, Department of Psychiatry & Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ghrelin and Saline in people with Major Depressive Disorder, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ghrelin-induced changes in motivation (time frame: 15-50 minutes after subcutaneous administration (ghrelin vs. saline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.