No registrations found.
ID
Source
Brief title
Health condition
Posttraumatic stress disorder (PTSD), Oxytocin, Neuroimaging
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
A promising candidate to improve treatment response in PTSD is the neuropeptide oxytocin (OT). OT is involved in several processes disrupted in PTSD, i.e. the fear response, social interaction and reward. In addition, OT is implicated in the pathophysiology of psychiatric disorders involving disturbed stress regulation as well as disrupted attachment and/or social deficits.
In this functional Magnetic Resonance Imaging (fMRI) study, the primary objective is to examine the acute effects of intranasal OT administration on emotional- and reward-related brain processes in PTSD patients (20 males/ 20 females) compared to traumatized healthy controls (20 males/ 20 females). Furthermore, we aim to examine gender differences in the effects of intranasal OT administration on functional (task-specific) brain activation and in structural anatomy (i.e. volume and white matter integrity) between PTSD patients and traumatized healthy controls.
Investigating the role of OT administration on emotional and reward-related processes in the brain may lead to novel strategies to improve treatment for PTSD.
Study objective
We expect that OT administration in PTSD patients and controls will dampen amygdala activity and increase reward sensitivity. We hypothesize to see a group by treatment interaction effect, such that the magnitude of the neural effects of OT treatment will differ between PTSD patients and controls.
Study design
Two fMRI sessions, one week apart.
Intervention
One dosis of intranasal oxytocin (40 IU) and one dosis of intranasal saline placebo (10 puffs) before fMRI.
Mirjam Zuiden, van
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 8913661
m.vanzuiden@amc.uva.nl
Mirjam Zuiden, van
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 8913661
m.vanzuiden@amc.uva.nl
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 ≥ 45.
Traumatized healthy controls:
1. CAPS-score < 15.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL3368 |
NTR-old | NTR3516 |
Other | IRB AMC / EUDRA CT : 2012_085 / 2012-001288-58; |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
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Olff, M. 2012 Bonding after trauma: on the role of social support and the oxytocin system in traumatic stress. European Journal of Psychotraumatology 2012, 3: 18597.