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.
Investigators
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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