Oxytocin DeficiencyNCT05319301
Identification and Clinical Relevance of an Oxytocin Deficient State (Melatonin Study)
A study testing Melatonin in people with Oxytocin Deficiency and Hypopituitarism, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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 sexual function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oxytocin Deficiency, Hypopituitarism, Hypothalamic Obesity
- What is being tested?
- Melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2022to 1 Nov 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Oxytocin Deficiency, Hypopituitarism, Hypothalamic Obesity, Pituitary Dysfunction, Central Diabetes Insipidus, Social Isolation
- Being tested
- Melatonin
- Keywords
- oxytocin, melatonin, hypopituitarism, vasopresin deficiency
- Medical subject headings
- Hypopituitarism, Sexual Infantilism, Diabetes Insipidus, Neurogenic, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
A single dose of melatonin (1.9 mg)
| Study group | Role | What they receive |
|---|---|---|
| Patients with hypopituitarism | Experimental | A single dose of melatonin administration Receives: Dietary Supplement: Melatonin |
| Healthy controls | Active comparator | A single dose of melatonin administration Receives: Dietary Supplement: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oxytocin concentration
Change in oxytocin concentration (pg/mL) after administration of 1.9 mg of melatonin orally.
Measured: Baseline blood exam (timepoint 0) and further blood collections after 30, 60, 90 and 120 minutes after baseline blood collection
Secondary outcomes (6)
Maximal change in oxytocin concentration (pg/mL)
Maximal change in oxytocin concentration (pg/mL) after administration of 1.9 mg of melatonin administered orally.
Measured: Within the two hours after the injection
Overall oxytocin secretion
Oxytocin area under the curve after administration of 1.9 melatonin administered orally
Measured: Within the two hours after the injection
Mood assessment
Correlation between Beck Depression Inventory-2 score (range from 0 to 63, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)
Measured: At baseline
Quality of life assessment
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)
Measured: At baseline
Impulsivity assessment
Correlation between Barratt Impulsiveness Scale (range from 30 to 120, higher scores indicate greater impulsivity) and baseline oxytocin concentration (pg/mL)
Measured: At baseline
Alexithymia assessment
Correlation between Toronto Alexithymia scales-20 score (range from 20 to 100, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Apr 2022
- Primary completion1 Sep 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxytocin DeficiencyStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319301
- Sponsor's protocol ID
- IIBSP-OXI-2021-112
- Status last verified
- Mar 2023
- First submitted
- 17 Mar 2022
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05319301
- Acronym / sponsor ID
- IIBSP-OXI-2021-112
- Conditions
- Oxytocin Deficiency, Hypopituitarism, Hypothalamic Obesity, Pituitary Dysfunction, Central Diabetes Insipidus, Social Isolation
- Keywords
- oxytocin, melatonin, hypopituitarism, vasopresin deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 8 Apr 2022 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with hypopituitarism | Experimental | Dietary Supplement: MelatoninA single dose of melatonin administration |
| Healthy controls | Active comparator | Dietary Supplement: MelatoninA single dose of melatonin administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| MelatoninA single dose of melatonin (1.9 mg) | Dietary supplement | Healthy controls, Patients with hypopituitarism |
Primary outcome
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.
6 secondary outcomes
Maximal change in oxytocin concentration (pg/mL)
Time frame: Within the two hours after the injection
Overall oxytocin secretion
Time frame: Within the two hours after the injection
Mood assessment
Time frame: At baseline
Quality of life assessment
Time frame: At baseline
Impulsivity assessment
Time frame: At baseline
Alexithymia assessment
Time frame: At baseline
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 9 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Oxytocin Deficiency and Hypopituitarism, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 2 inclusion and 15 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 9 Apr 2024. 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 Spain. 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?
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). 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 9 Apr 2024.