NCT07815587

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Sep 2026Dec 2027

Study Start

First participant enrolled

September 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

1.2 years

First QC Date

September 3, 2026

Last Update Submit

September 8, 2026

Conditions

Psychotic DisorderSCHIZOPHRENIA 1 (Disorder)Intramuscular Injection

Outcome Measures

Primary Outcomes (1)

  • 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

    At the ultrasound examination (single study visit).

Study Arms (1)

Group 1: Patients receiving depot antipsychotic medication (n=30)

Group 2: Healthy volunteers (n=30)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults receiving depot antipsychotic medication

You may qualify if:

  • adults receiving depot antipsychotic medication and able to provide informed consent.
  • Healthy volunteers: adults able to provide informed consent.

You may not qualify if:

  • Acute infections at the injection site
  • Previous surgery that makes ultrasound examination difficult

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 11, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

September 11, 2026

Record last verified: 2026-09