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Effects of Ghrelin Administration on Motivation

Plain-language guide to NCT06576440: not phased randomized trial of Ghrelin, 24 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06576440
Phase
not phased
Status
completed
Start
2024-09-02
Completion (planned or actual)
2024-12-20
Participants
24 (actual)
Design
randomized, triple-blind, basic_science
Conditions studied
Major Depressive Disorder
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Ghrelin.

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.

It had two arms (groups): Major depressive disorder (experimental) and Healthy control participants (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).

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).

The registry classes the interventions as drug.

Who Took Part

The registry lists 24 actual participants took part.

It was open to people of any sex aged from 20 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 0 inclusion and 3 exclusion criteria; among the exclusions: participation in the neuroimaging part of nct05120336.

How the Study Was Run

Design: randomized, crossover and triple-blind.

Random assignment meant chance, not the researchers, decided who got Ghrelin and who got the comparison, which limits bias.

Each person switched between Ghrelin and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Ghrelin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2024-09-02 with completion listed for 2024-12-20.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Ghrelin-induced changes in motivation (time frame: 15-50 minutes after subcutaneous administration (ghrelin vs. saline)). Ghrelin-induced changes in Resting Energy Expenditure (time frame: Pre injection versus 50-65 minutes after injection (compared to saline)). Ghrelin-induced changes in mood.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Ghrelin in 24 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Ghrelin compound page, all human trials.

Our Notes on the Compound

Ghrelin: A 28-amino-acid stomach hormone that signals hunger and triggers growth hormone release; studied in human trials as an infusion.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.