Posttraumatic Stress Disorder (PTSD) according to criteria in the DSM-IV MedDRA version: 14.1 Level: PT Classification code 10036316 Term: Post-traumatic stress disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 compared to traumatized healthy controls. 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. ;Secondary Objective: 1.We will examine possible influences of attachment style, social support, alexithymia, emotional numbing, anhedonia and history of (childhood) trauma and life events on the effects of OT administration. 2.We will investigate possible influences of (epi)genetic variations on the effect of OT administration. 3.We will investigate the potential role of endogenous steroid hormone levels (i.e. estrogen and testosterone) in the effect of OT administration. 4.Psychobiological measures such as reaction times and accuracy on the face-matching and reward tasks and heart rate, heart rate variability and skin conductance response during task execution will be collected to investigate possible effects of OT administration on these psychobiological processes. 5.OT levels will be assessed from saliva to study the effects of intranasal OT administration.;Primary end point(s): 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 controls. ;Timepoint(s) of evaluation of this end point: After the second fMRI session is finished | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Answers to various questionnaires will be used to examine potential associations between the main study outcome and representations of attachment style, social support, alexithymia, emotional numbing, anhedonia and history of (childhood) trauma and life events. 2. (Epi)gentic variation will be assessed to investigate potential associations with the main study outcome. 3. Salivary levels of estradiol and testosterone will be measured during both fMRI sessions to assess the role of endogenous steroid hormone levels. 4. Reaction times and accuracy will be calculated on the face-matching and reward tasks. Heart rate, heart rate variability and skin conductance response will be measured during the fMRI protocol. 5. We will measure OT in saliva at two time points during each fMRI session to investigate the influence of intranasal OT administration on salivary OT levels. ;Timepoint(s) of evaluation of this end point: After the second fMRI session is finished | — |
Countries
Netherlands
Contacts
Public ContactOlff- Oxytocin research group
Academic Medical Center, Department of Psychiatry, Center for Anxiety Disorders
Outcome results
None listed