Psychotic DisorderULPSYKNCT07815587
Ultrasound Assessment of Gluteal Muscle in Patients Receiving Depot Antipsychotics and Healthy Volunteers
An observational study of Psychotic Disorder and SCHIZOPHRENIA 1 (Disorder), run by St. Olavs Hospital.
Trial summary
This observational study will use ultrasound to assess the gluteal musculature in patients receiving depot antipsychotic medication and in healthy volunteers. The study aims to improve knowledge about anatomical conditions relevant to intramuscular depot injections. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychotic Disorder, SCHIZOPHRENIA 1 (Disorder), Intramuscular Injection
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adults receiving depot antipsychotic medication
Who may be able to join
- adults receiving depot antipsychotic medication and able to provide informed consent.
- Healthy volunteers: adults able to provide informed consent.
Who cannot join
- Acute infections at the injection site
- Previous surgery that makes ultrasound examination difficult
About this study
Official title: Ultrasound-Guided Assessment of Gluteal Muscle in Patients Receiving Depot Antipsychotics and Healthy Volunteers
This observational study will use ultrasound to assess the gluteal musculature in patients receiving depot antipsychotic medication and in healthy volunteers. The study aims to improve knowledge about anatomical conditions relevant to intramuscular depot injections.
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Patients receiving depot antipsychotic medication (n=30) | Group 2: Healthy volunteers (n=30) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound-based assessment of gluteal anatomy, including measurements relevant to identifying an appropriate intramuscular injection site.
Primary outcome is skin muscle (gluteus) distanse in millimeter
Measured: At the ultrasound examination (single study visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisorderStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SINTEF Health Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815587
- Sponsor's protocol ID
- 987095
- Acronym
- ULPSYK
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Assessment of Gluteal Muscle in Patients Receiving Depot Antipsychotics and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07815587
- Acronym / sponsor ID
- ULPSYK / 987095
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- SINTEF Health Research
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Sep 2026 (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.
This observational study will use ultrasound to assess the gluteal musculature in patients receiving depot antipsychotic medication and in healthy volunteers. The study aims to improve knowledge about anatomical conditions relevant to intramuscular depot injections.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1: Patients receiving depot antipsychotic medication (n=30) | – | –Group 2: Healthy volunteers (n=30) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults receiving depot antipsychotic medication
Key inclusion criteria (2 listed)
- adults receiving depot antipsychotic medication and able to provide informed consent.
- Healthy volunteers: adults able to provide informed consent.
Key exclusion criteria (2 listed)
- Acute infections at the injection site
- Previous surgery that makes ultrasound examination difficult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ultrasound-based assessment of gluteal anatomy, including measurements relevant to identifying an appropriate intramuscular injection site.
Time frame: At the ultrasound examination (single study visit).
Primary outcome is skin muscle (gluteus) distanse in millimeter
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorder and SCHIZOPHRENIA 1 (Disorder), run by St. Olavs Hospital.
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 2 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: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Ultrasound-based assessment of gluteal anatomy, including measurements relevant to identifying an appropriate intramuscular injection site. (time frame: At the ultrasound examination (single study visit).). 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 11 Sep 2026.