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Boosting oxytocin after trauma.

Completed
Conditions
PTSD, trauma-related psychopathology
Registration Number
NL-OMON27745
Lead Sponsor
Academic Medical Center - University of Amsterdam
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
Inclusion Criteria

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;

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
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.
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