Clinical trial • Phase IV • Endocrinology | Rare Disease
Oxytocin for Central diabetes insipidus
Phase IV trial of Oxytocin for Central diabetes insipidus.
Overview
- Trial Therapeutic Area
- Endocrinology | Rare Disease
- Trial Disease
- Central diabetes insipidus
- Trial Stage
- Phase IV
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 11-09-2024
- First CTIS Authorization Date
- 08-01-2025
Trial design
Randomised, oxytocin: intranasal oxytocin 24 iu twice daily for 28 (+/-2) days (active arm). comparator: placebo nasal spray (will contain 0.9% sodium chloride and no oxt); placebo identical in volume and labelling but not container system.-controlled Phase IV trial across 2 sites in Netherlands, Germany.
- Randomised
- Yes
- Comparator
- OXYTOCIN: intranasal oxytocin 24 IU twice daily for 28 (+/-2) days (active arm). Comparator: placebo nasal spray (will contain 0.9% sodium chloride and no OXT); placebo identical in volume and labelling but not container system.
- Target Sample Size
- 70
- Trial Duration For Participant
- 28
Eligibility
Recruits 70 No vulnerable population selected. Trial enrols adult patients (>18 years) only. Informed consent forms for adult participants are provided (subject information and informed consent documents listed in the trial documents). No assent or parental consent procedures are indicated..
- Pregnancy Exclusion
- Pregnancy and breastfeeding within the last 8 weeks
- Vulnerable Population
- No vulnerable population selected. Trial enrols adult patients (>18 years) only. Informed consent forms for adult participants are provided (subject information and informed consent documents listed in the trial documents). No assent or parental consent procedures are indicated.
Inclusion criteria
- {"criterion_text":"- Adult patients with a confirmed diagnosis of central diabetes insipidus based on accepted criteria\n- Heightened anxiety levels (STAI – Trait subscale ≥ 39 score points) or alexithymia levels (im- paired ability to identify and describe feelings; TAS-20 total ≥ 52 score points)\n- Stable hormone replacement therapy for at least three months with desmopressin and, in case of additional anterior pituitary deficiencies, with the respective substitution therapies\n- Adult patients aged over 18 years"}
Exclusion criteria
- {"criterion_text":"- Participation in a trial with investigational drugs within 30 days\n- Pregnancy and breastfeeding within the last 8 weeks\n- Active substance use disorder within the last six months\n- Consumption of alcoholic beverages >15 drinks/week\n- Unwilling to use a medically acceptable form of contraception throughout the study period (female of childbearing potential only)\n- Current or previous psychotic disorder (e.g., schizophrenia spectrum disorder)\n- Prolonged QTc-time > 470 ms assessed with a 12-lead electrocardiogram.\n- Hypersensitivity to the excipients substances methyl p-hydroxybenzoate (E218) and propyl p- hydroxybenzoate (E216)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Trait anxiety level and correct classifications of facial & body expression after 28 (+/-2) days of treatment assessed with the STAI-T and the EmBody/EmFace Task. ▪ The STAI-T comprises 20 items scoring 1-4 points each. ▪ The EmBody/EmFace comprises 84 items scoring correct or incorrect each.","definition_or_measurement_approach":"Assessment with the STAI-T (20 items, 1-4 points each) for trait anxiety and the EmBody/EmFace Task (84 items, each scored correct or incorrect) after 28 (+/-2) days of treatment."}
Secondary endpoints
- {"endpoint_text":"- Emotion recognition and empathy","definition_or_measurement_approach":""}
- {"endpoint_text":"- Hormonal and subjective response to psychological stress","definition_or_measurement_approach":""}
- {"endpoint_text":"- Amygdala and subjective response in the functional MRI scan","definition_or_measurement_approach":""}
- {"endpoint_text":"- Further psychological outcomes","definition_or_measurement_approach":""}
- {"endpoint_text":"- Metabolic outcomes","definition_or_measurement_approach":""}
- {"endpoint_text":"- Objective assessment of a close third person","definition_or_measurement_approach":""}
- {"endpoint_text":"- Safety outcome","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 70
- Recruitment Window Months
- 22
- Consent Approach
- Informed consent to be obtained from adult participants (>18 years). Subject information and informed consent forms are provided (documents listed include adult ICFs and patient-facing materials, including German and Dutch translations). No assent or parental consent is indicated.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 70
Netherlands
- Earliest CTIS Part Ii Submission Date
- 16-12-2024
- Latest Decision Or Authorization Date
- 08-01-2026
- Processing Time Days
- 388
- Number Of Sites
- 1
- Number Of Participants
- 50
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Rg5 Erasmus MC
- Contact Person Name
- Julie Refardt
- Contact Person Email
- j.refardt@erasmusmc.nl
- Number Of Participants
- 50
Germany
- Earliest CTIS Part Ii Submission Date
- 18-08-2025
- Latest Decision Or Authorization Date
- 29-12-2025
- Processing Time Days
- 133
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik für Endokrinologie, Stoffwechsel- und Ernährungsmedizin
- Contact Person Name
- Linus Haberbosch
- Contact Person Email
- linus.haberbosch@charite.de
- Number Of Participants
- 20
Sponsor
Primary sponsor
- Full Name
- Universitaetsspital Basel
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- OXYTOCIN
- Active Substance
- Oxytocin
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Intranasal (nasal spray)
- Route
- Intranasal
- Authorisation Status
- Authorised in EU/Switzerland (licensed product Syntocinon®)
- Starting Dose
- 24 IU intranasally, twice daily
- Dose Levels
- 24 IU twice daily
- Frequency
- Twice daily
- Maximum Dose
- 48 IU per day
- Investigational Product Name
- Placebo nasal spray
- Active Substance
- 0.9% sodium chloride (no OXT)
- Modality
- Other
- Routes Of Administration
- Intranasal (nasal spray)
- Route
- Intranasal
- Authorisation Status
- Not applicable (placebo)
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