Skip to content

Targeted glucocorticoid administration to improve safety learning in posttraumatic stress disorder patients with HPA axis dysregulation

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516427-13-00
Enrollment
190
Registered
2024-10-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder (PTSD)

Brief summary

For substudy A, the main study parameters are (1) early life adversity, (2) Hypothalamic-pituitary-adrenal axis functioning, and (3) epigenetic mechanisms. For substudy B, the main study parameter regards retention of the safety memory within the VR contextual fear conditioning environment.

Detailed description

For substudy A, this includes (1) salivary cortisol response curve to the SECPT ( a validated stress test) and (2) treatment response to focused treatment for PTSD. For substudy B, this includes the following MRI endpoints (1) BOLD-fMRI response during fear extinction, (2) BOLD-fMRI general amygdala responsiveness during viewing of emotional faces (3) Resting state fMRI functional coupling between vmPFC and amygdala(4) Structural MRI (T1-weighted MP-RAGE) and DTI scans.

Interventions

DRUGPlacebo: PL1
DRUGRoute of administration: Oral use
DRUGHydrocortison DMB 20 mg
DRUGtabletten

Sponsors

Stichting Radboud universitair medisch centrum
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
For substudy A, the main study parameters are (1) early life adversity, (2) Hypothalamic-pituitary-adrenal axis functioning, and (3) epigenetic mechanisms. For substudy B, the main study parameter regards retention of the safety memory within the VR contextual fear conditioning environment.

Secondary

MeasureTime frame
For substudy A, this includes (1) salivary cortisol response curve to the SECPT ( a validated stress test) and (2) treatment response to focused treatment for PTSD. For substudy B, this includes the following MRI endpoints (1) BOLD-fMRI response during fear extinction, (2) BOLD-fMRI general amygdala responsiveness during viewing of emotional faces (3) Resting state fMRI functional coupling between vmPFC and amygdala(4) Structural MRI (T1-weighted MP-RAGE) and DTI scans.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026