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NCT Number: NCT05319301

Identification and Clinical Relevance of an Oxytocin Deficient State (Melatonin Study)

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 sexual function. Hypopituitarism is associated with increased obesity, increased psychopathology, sexual and prosocial dysfunction despite appropriate hormone replacement. A few studies suggest the existence of a possible OT deficient state in hypopituitarism. In animal models, melatonin has shown to increase OT release.

This study is designed to evaluate oxytocin values after administration of melatonin in adults (healthy volunteers and patients with hypopituitarism).

The investigators hypothesize that OT response will be blunted following melatonin in patients with hypopituitarism compared to healthy controls.

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Key information

Conditions

Oxytocin Deficiency Behavior Brain Diseases Central Diabetes Insipidus Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Insipidus Diabetes Insipidus, Neurogenic Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gonadal Disorders Gonadal Dysgenesis Hypogonadism Hypopituitarism Hypothalamic Diseases Hypothalamic Obesity Kidney Diseases Male Urogenital Diseases Nervous System Diseases Pituitary Diseases Pituitary Dysfunction Sexual Infantilism Social Behavior Social Isolation Urogenital Abnormalities Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

melatonin

Dietary Supplement

A single dose of melatonin (1.9 mg)

Primary outcomes

  1. Change in oxytocin concentration

    Time frame: Baseline blood exam (timepoint 0) and further blood collections after 30, 60, 90 and 120 minutes after baseline blood collection

    Change in oxytocin concentration (pg/mL) after administration of 1.9 mg of melatonin orally.

Secondary outcomes

  1. Maximal change in oxytocin concentration (pg/mL)

    Time frame: Within the two hours after the injection

    Maximal change in oxytocin concentration (pg/mL) after administration of 1.9 mg of melatonin administered orally.

  2. Overall oxytocin secretion

    Time frame: Within the two hours after the injection

    Oxytocin area under the curve after administration of 1.9 melatonin administered orally

  3. Mood assessment

    Time frame: At baseline

    Correlation between Beck Depression Inventory-2 score (range from 0 to 63, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)

  4. Quality of life assessment

    Time frame: At baseline

    Correlation between 36 item- Short Form Health Survey score (range from 0 to 100, the higher scores indicate better health status) and baseline oxytocin concentration (pg/mL)

  5. Impulsivity assessment

    Time frame: At baseline

    Correlation between Barratt Impulsiveness Scale (range from 30 to 120, higher scores indicate greater impulsivity) and baseline oxytocin concentration (pg/mL)

  6. Alexithymia assessment

    Time frame: At baseline

    Correlation between Toronto Alexithymia scales-20 score (range from 20 to 100, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Registry information

Official study title

Identification and Clinical Relevance of an Oxytocin Deficient State Following Melatonin Administration in Patients With Hypopituitarism: a Proof-of-concept, Physiopathological Study With a Control Group

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2022
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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