|- candidate number||13119|
|- NTR Number||NTR3516|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-jul-2012|
|- Secondary IDs||2012_085 / 2012-001288-58; IRB AMC / EUDRA CT|
|- Public Title||The effect of oxytocin on brain processes in PTSD.|
|- Scientific Title||Boosting oxytocin after trauma: The effects of intranasal oxytocin administration on emotional and motivational brain processes in PTSD.|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Oxytocin, Post traumatic stress disorder|
|- 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.
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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||6-jul-2012|
|- planned closingdate||1-jul-2014|
|- Target number of participants||80|
|- Interventions||One dosis of intranasal oxytocin (40 IU) and one dosis of intranasal saline placebo (10 puffs) before fMRI.|
|- 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.
|- Timepoints||Two fMRI sessions, one week apart.|
|- Trial web site||www.amcpsychiatrie.nl/booster|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||PhD. Mirjam Zuiden, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M. Olff|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||Olff, M., W. Langeland, A. Witteveen, D. Denys, 2010. A psychobiological rationale for oxytocin in the treatment of posttraumatic stress disorder. CNS spectr., v. 15, no. 8, p. 522-30.
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.
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||9-jul-2012 - 26-jul-2012|