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The effect of oxytocin on brain processes in PTSD.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20321
Enrollment
80
Registered
2012-07-09
Start date
2012-07-06
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic stress disorder (PTSD), Oxytocin, Neuroimaging

Interventions

One dosis of intranasal oxytocin (40 IU) and one dosis of intranasal saline placebo (10 puffs) before fMRI.

Sponsors

Academic Medical Center (AMC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 – 65 years; 2. Capable to read and comprehend the Dutch language; 3. Eligibility for MRI; 4. Exposed to a potentially traumatic event. PTSD patients: 1. Current PTSD diagnosis; 2. CAPS score &#8805; 45. Traumatized healthy controls: 1. CAPS-score < 15.

Exclusion criteria

Exclusion criteria: 1. Any severe or chronic systemic disease; 2. Current psychotic, bipolar, substance-related, severe personality disorder, or mental retardation; 3. Current severe depressive disorder; 4. Prominent current suicidal risk or homicidal ideation; 5. Severe cognitive impairment or a history of organic mental disorder; 6. History of neurological disorders (e.g. traumatic brain injury, seizure history); 7. Reports of ongoing traumatization (e.g. in case of partner violence as index adult trauma); 8. 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; 9. Use of certain medication: prostaglandins, certain anti-migraine medications (ergot alkaloids), ß-adrenergic receptor-blocking agents, systemic glucocorticoids and psychopharmacological medication; 10. Sensitivity or allergy for OT or its components (e.g. methylhydroxybenzoate and propylhydroxybenzoate); 11. Female participants: pregnancy and breast feeding (NB: female participants with childbearing potential must have a negative pregnancy test). Traumatized healthy controls only: 1. (Lifetime history of) PTSD diagnosis, major depressive disorder; 2. Current DSM-IV axis 1 disorder.

Design outcomes

Primary

MeasureTime frame
The main outcome measures of this study are the acute effects of intranasal OT administration on emotional- and reward related brain processes in men and women diagnosed with PTSD compared to traumatized healthy men and women.

Secondary

MeasureTime frame
1. Gender differences in the effects of intranasal OT administration on functional (task-specific) brain activation between PTSD patients and traumatized healthy controls will be investigated; 2. Answers to various questionnaires will be used to examine potential associations between the main study outcome and representations of attachment style, social support and history of (childhood) trauma and (workrelated) life events; 3. (Epi)genetic variation will be assessed to investigate potential associations with the main study outcome.

Contacts

Public ContactMirjam Zuiden, van

Meibergdreef 5

m.vanzuiden@amc.uva.nl+31 (0)20 8913661

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)