Boosting oxytocin after trauma.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR3190
• Date of registration: 23/11/2011
• Primary sponsor: Academic Medical Center (AMC)
• Public title: Boosting oxytocin after trauma.
• Scientific title: BONDS: Boosting Oxytocin after trauma: Neurobiology and the Development of Stress-related psychopathology . - BONDS
• Date of first enrolment: 16/1/2012
• Target sample size: 220
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3190
• Study type: intervention
• Study design: Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: Mirjam Zuiden, van

• Name: M. Olff

Key inclusion & exclusion criteria

Inclusion criteria: 1. Presentation at the Trauma Unit or Emergency Department after a potentially traumatic event, according to PTSD A1 criterion in the DSM-IV;

2. Trauma Screening Questionnaire (TSQ) ≥ 5, or Peritraumatic Distress Inventory (PDI) ≥ 17 between 24 and 72 hours after trauma exposure;

3. Age 18 ? 65 years;

4. Capable to read and comprehend either the Dutch or English language.
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. Evidence of PTSD or depression immediately prior to the index trauma;

7. History of neurological disorders (e.g., traumatic brain injury, seizure history);

8. Reports of ongoing traumatization (e.g., in case of partner violence as index adult trauma);

9. 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;

10. Use certain medications: prostaglandins, certain anti-migraine medications (ergot alkaloids), ß-adrenergic receptor-blocking agents, and systemic glucocorticoids;

11. Sensitivity or allergy for OT or its components (e.g., methylhydroxybenzoate and propylhydroxybenzoate);

12. Impaired consciousness, amnesia or confusion (due to for example head injury) (Glasgow Coma Scale lower than 13);

13. Female participants: Pregnancy and breast feeding (NB. Female participants with childbearing potential must have a negative pregnancy test).

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Posttraumatic stress disorder (PTSD), Trauma related complaints (e.g. anxiety, depression)

Intervention(s)

Intranasal oxytocin (2dd 40 IU for 7 days), or intranasal saline placebo (2dd 10 puffs for 7 days). The intranasal treatments start approximately on day 9 post trauma.

Primary Outcome(s)

Differences in PTSD symptom severity measured with the CAPS at one-and-a-half months post trauma follow-up.

Secondary Outcome(s)

1. Differences between intervention groups in depression and general anxiety symptoms, neuroendocrine and psychophysiological measures, perceived social support, and psychological functioning after one week of intranasal treatment, and on one and a half, three and six months post trauma exposure;

2. Difference in PTSD symptoms severity (CAPS scores) between the two trial arms (i.e. OT and
placebo) at three and six months post trauma follow-up;

3. Potential associations between the main study outcomes 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.

Secondary ID(s)

2011_273 / 2011-004177-83;

Source(s) of Monetary Support

ZON-MW, The Netherlands Organization for Health Research and Development