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NCT06348472
The Predictive Role of Immune-inflammatory Biomarkers and Their Interaction With the Oxytocin System in Trauma-related Psychotherapy Responsiveness
trial in Posttraumatic Stress Disorder in 100 participants. Currently enrolling.
1 March 2028
Quick facts
| Lead sponsor | Shalvata Mental Health Center |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 14 March 2024 |
| Primary completion | 1 March 2028 |
| Estimated completion | 1 March 2028 |
| Sites | 1 location across Israel |
Conditions studied
- Posttraumatic Stress Disorder — all drugs for Posttraumatic Stress Disorder →
Sponsor
Shalvata Mental Health Center — full company profile →
Who can join
Adults 18 to 80, any sex, with Posttraumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Despite a range of treatments for posttraumatic stress disorder (PTSD), only a small proportion of patients reach full symptomatic remission. Recent developments in the field of neuroscience have been providing compelling evidence to suggest that neurobiological determinants might influence not only the emergence of PTSD, but also its resistance to treatment. Immune-inflammation regulatory processes were found to be active during recovery from PTSD, potentially through interactive relationship with the oxytocin secretion system. This innovative longitudinal study aims to examine the role of inflammatory biomarkers and their interactive effect with the oxytocin (OT) system on the development of PTSD and on treatment response among patients with PTSD symptoms undergoing psychotherapy treatment. Patients (N = 100) suffering from trauma-related distress will be recruited from the trauma clinic in Shalvata Mental Health Center. Participants will be followed for 12 weeks of once-a-week psychotherapy sessions. They will be measured for endogenous OT level and cytokines levels in saliva before and after sessions 1, 6, and 12, and will complete psychotherapy outcome self-report questionnaires following each of these sessions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06348472
- Europe PMC full search
- ASCO Meeting Library
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Other Shalvata Mental Health Center trials
Trials by the same sponsor.
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- NCT07455344 — Mechanisms and Outcomes of Children and Adolescent Psychotherapy · recruiting
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- NCT06332066 — Oxytocin Administration to Therapists and Its Effects on Patient-perceived Attunement and Responsiveness · Phase 1 · unknown
- NCT05865288 — The Moderating Role of Baseline Oxytocin on Its Psychotherapy-facilitating Effects Among Patients With Eating Disorders · Phase 1 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06348472 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shalvata Mental Health Center
- Last refreshed: 28 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06348472.
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