Status:
COMPLETED
Identification and Clinical Relevance of an Oxytocin Deficient State (Melatonin Study)
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Conditions:
Oxytocin Deficiency
Hypopituitarism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Oxytocin (OT) is a hypothalamic peptide that enters the peripheral circulation via the posterior pituitary gland. OT plays a key role in regulating appetite, psychopathology, prosocial behavior and se...
Eligibility Criteria
Inclusion
- Patients with hypopituitarism (HYPO) (\>1 pituitary hormone deficiency) and stable hormone replacement for the prior three months
- At least one clinical sign of hypothalamic damage
Exclusion
- uncorrected hormone deficiency
- creatinine \>1.5mg/dL
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5x upper limit of normal
- hematocrit less than 30%
- suicidality or active psychosis
- participation in a trial with investigational drugs within 30 days
- using a high glucocorticoid dose
- vigorous physical exercise
- alcohol intake within 24 hours before the study participation
- evidence of any acute illness or any illness that the Investigator determines could interfere with study participation or safety
- pregnancy or breastfeeding for last 8 weeks
- known allergies towards melatonin
- patients refusing or unable to give written informed consent
- patients receiving fluvoxamine and/or impossibility to stop hypnotics 48 hours prior to the study visit.
- Additionally for healthy controls: the presence of brain or pituitary tumor, radiation involving the hypothalamus or pituitary, history of hypopituitarism or receiving testosterone or glucocorticoids esters.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05319301
Start Date
April 1 2022
End Date
November 1 2023
Last Update
April 9 2024
Active Locations (1)
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1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041