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

Phase 2

Completed

• Conditions: posttraumatic stress disorder (PTSD) and stress disorder; 10002861

• Registration Number: NL-OMON39817
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-01-01
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 83

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

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)
* Female participants: pregnancy and breast feeding (NB. Female participants with childbearing potential must have a negative pregnancy test).
Traumatized healthy controls only:
* (lifetime history of) PTSD diagnosis, major depressive disorder.
* Current DSM-IV axis 1 disorder

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified