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Clinical Trials/EUCTR2012-001288-58-NL
EUCTR2012-001288-58-NL
Active, not recruiting
Not Applicable

Boosting oxytocin after trauma: The effects of intranasal oxytocin administration on emotional and motivational brain processes in PTSD - The effect of oxytocin in PTSD

Academic Medical Center0 sitesMarch 27, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Academic Medical Center
Status
Active, not recruiting
Last Updated
10 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 27, 2012
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Academic Medical Center

Eligibility Criteria

Inclusion Criteria

  • Age 18 – 65 years
  • Capable to read and comprehend the Dutch language
  • Eligibility for MRI (i.e. no metals, pacemakers or claustrophobia)
  • Exposed to a potentially traumatic event, according to PTSD A1 criterion in the DSM\-IV (minimal 1 month ago), quantified as a score of 1 or higher on the Life Events Checklist (LEC).
  • PTSD patients:
  • Current PTSD diagnosis
  • CAPS score \= 45
  • Traumatized healthy controls:
  • CAPS\-score \< 15
  • Are the trial subjects under 18? no

Exclusion Criteria

  • Any severe or chronic systemic disease
  • Current psychotic, bipolar, substance\-related, severe personality disorder, or mental retardation
  • Current severe depressive disorder
  • Prominent current suicidal risk or homicidal ideation
  • Severe cognitive impairment or a history of organic mental disorder
  • History of neurological disorders (e.g., traumatic brain injury, seizure history)
  • Reports of ongoing traumatization (e.g., in case of partner violence as index adult trauma)
  • Evidence of clinically significant and unstable medical conditions in which OT administration is contra\-indicative such as cardiovascular, gastro\-intestinal, pulmonary, severe renal, endocrine or hematological disorders, glaucoma, history of epilepsy, or a stroke or myocardial infarction within the past year
  • Use of certain medication: prostaglandins, certain anti\-migraine medications (ergot alkaloids), ß\-adrenergic receptor\-blocking agents, systemic glucocorticoids and psychopharmacological medication.
  • Sensitivity or allergy for OT or its components (e.g. methylhydroxybenzoate and propylhydroxybenzoate)

Outcomes

Primary Outcomes

Not specified

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