Boosting oxytocin after trauma.
- Conditions
- PTSD, trauma-related psychopathology
- Registration Number
- NL-OMON27745
- Brief Summary
Olff, M., W. Langeland, A. Witteveen, D. Denys, 2010. A psychobiological rationale for oxytocin in the treatment of posttraumatic stress disorder. CNS spectr., v. 15, no. 8, p. 522-30. <br><br> Frijling, J. L., van Zuiden, M., Koch, S. B., Nawijn, L., Goslings, J. C., Luitse, J. S., ... & Olff, M. (2014). Efficacy of oxytocin administration early after psychotrauma in preventing the development of PTSD: study protocol of a randomized controlled trial. BMC psychiatry, 14(1), 92.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 220
1. Presentation at the Trauma Unit or Emergency Department after a potentially traumatic event, according to PTSD A1 criterion in the DSM-IV;
2. Trauma Screening Questionnaire (TSQ) ≥ 5, or Peritraumatic Distress Inventory (PDI) ≥ 17 between 24 and 72 hours after trauma exposure;
1. Any severe or chronic systemic disease;
2. Current psychotic, bipolar, substance-related, severe personality disorder, or mental retardation;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in PTSD symptom severity measured with the CAPS at one-and-a-half months post trauma follow-up.<br>fMRI substudy: brain reactivity and connectivity measures to emotional face matching and traumatic script imagery tasks.
- Secondary Outcome Measures
Name Time Method 1. Differences between intervention groups in depression and general anxiety symptoms, neuroendocrine and psychophysiological measures, perceived social support, and psychological functioning after one week of intranasal treatment, and on one and a half, three and six months post trauma exposure;<br /><br>2. Difference in PTSD symptoms severity (CAPS scores) between the two trial arms (i.e. OT and<br>placebo) at three and six months post trauma follow-up;<br /><br>3. Potential associations between the main study outcomes and gender, genetic variation, subjective measures of social support, representations of attachment style, coping style, subjective health complaints, affect, quality of life, trauma type, and history of (childhood) trauma and life events.