Posttraumatic Stress Disorder (PTSD) according to criteria in the DSM-IV MedDRA version: 14.0 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: ? Presentation at the Trauma Unit or Emergency Department after a potential traumatic event, according to PTSD A1 criterion in the DSM-IV ? Trauma Screening Questionnaire (TSQ) > 5 between 24 and 72 hours after trauma exposure ? Age 18 – 65 years ? Significant other (i.e. best friend, partner or family member) willing to join the social support intervention ? Capable to read and comprehend either the Dutch or English language Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 260 F.1.3 Elderly (>=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 ? Evidence of PTSD or depression immediately prior to the index trauma ? 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 prostaglandins and certain anti-migraine medications (ergot alkaloids) ? Sensitivity or allergy for OT or its components (e.g., methylhydroxybenzoate and propylhydroxybenzoate) ? Impaired consciousness, or amnesia or confusion (due to for example head injury) (Glasgow Coma Scale lower than 13) ? Female participants: pregnancy and breast feeding (NB. Female participants with childbearing potential must have a negative pregnancy test).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In recently traumatized individuals (at the latest on day ten post trauma exposure) with a high initial level of distress, we aim to assess the effectiveness of intranasal OT and a semi-structured social support intervention in preventing symptoms of PTSD at one and three months post trauma follow-up.;Secondary Objective: • Investigate the effects of oxytocine (OT) and social support intervention on depression and general anxiety symptoms, psychophysiological and neuroendocrine measures, perceived social support and psychological functioning after one week, and at one, three and six months post trauma follow-up; • Examine potential associations between the main study outcome and gender, genetic variation, subjective measures of social support, representations of attachment style, coping style, subjective health complaints, affect, quality of life, trauma type and history of (childhood) trauma and life events.;Primary end point(s): The main study outcome is the difference in PTSD symptoms severity (CAPS scores) between the four trial arms (i.e. oxytocine (OT) + social support; placebo + social support; OT + no intervention additive to care as usual; placebo + no intervention additive to care as usual) at one and three months post trauma follow-up.;Timepoint(s) of evaluation of this end point: 1 and 3 months post trauma | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Difference between the four groups in depression and general anxiety symptoms, neuroendocrine and psychophysiological measures, perceived social support and psychological functioning after one week of OT treatments, and one, three and six months post trauma exposure. • Potential associations between the main study outcome and gender, genetic variation, subjective measures of social support, representations of attachment style, coping style, subjective health complaints, affect, quality of life, trauma type, history of (childhood) trauma and life events.;Timepoint(s) of evaluation of this end point: 7-10 days after trauma; 14-17 days after trauma; 1, 3, 6 months after trauma | — |
Countries
Netherlands
Contacts
Public ContactOlff Oxytocine-Research Group
Academic Medical Center, Department of Psychiatry, Center for Anxiety Disorders
Outcome results
None listed