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Oxytocin in PTSD: Effectiveness in addition to NET.


- candidate number14036
- NTR NumberNTR3724
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-nov-2012
- Secondary IDsNL41223.018.12 / 2012_197; CCMO / IRB AMC
- Public TitleOxytocin in PTSD: Effectiveness in addition to NET.
- Scientific TitleOxytocin in PTSD: Effectiveness as addition to Narrative Exposure Therapy.
- ACRONYMOPEN
- hypothesisWe expect a faster reduction (steeper curve) in the participants who receive oxytocin compared to placebo in addition to NET, as well as lower symptom levels at 1-3 weeks and 14-16 weeks post-treatment.
- Healt Condition(s) or Problem(s) studiedPost-Traumatic Stress Disorder (PTSD)
- Inclusion criteria1. Patients with a diagnosis of chronic PTSD (> 3 months);
2. CAPS score of ≥ 50 ;
3. Age 18 to 65 years;
4. Written informed consent;
5. Eligible for exposure therapy 6. Capable to read and comprehend either the Dutch or English language.
- Exclusion criteria1. Suicidal risk;
2. Presence of any of the following DSM IV diagnoses, at present or in the past: psychotic disorder incl. schizophrenia, a bipolar disorder, or excessive substance related or eating disorder over the past 6 months;
3. Female patients being pregnant (NB. female patients with childbearing potential must have a negative pregnancy test each month);
4. Female patients with an active pregnancy wish;
5. Female patients giving lactation to their child;
6. Diagnosis of current severe depressive disorder (with psychotic features and/or high suicidal intent);
7. An organic disorder/cognitive impairment;
8. Patients using psychotropic medications will be required to have been on a stable dose for at least 2 months before their pre-treatment assessment (T0). Psychotropic medication already used at the pre-treatment assessment will be maintained until the post-treatment assessment. No psychotropic medication will be prescribed for participants during the study unless they develop serious depressive symptoms. A medication protocol in accordance with clinical guidelines (A.P.A., 2004; Institute of Medicine (IOM), 2008; National Institute for Clinical Excellence, 2005) will be used;
9. Use of prostaglandins and certain anti-migraine medications (ergot alkaloids), systemic glucocorticoids and beta-blockers;
10. Sensitivity or allergy for oxytocin or its components (e.g. methylhydroxybenzoaat en propylhydroxybenzoaat);
11. Evidence of clinically significant and unstable medical conditions in which OT administration is contra-indicative, including cardiovascular, gastro-intestinal, pulmonary, severe renal, endocrine or hematological disorders, glaucoma, history of epilepsy, and stroke or myocardial infarction within the past year.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-dec-2012
- planned closingdate1-nov-2015
- Target number of participants24
- InterventionsIntranasal oxytocin (24 IU administered weekly prior to each NET treatment session for max 16 weeks), or intranasal saline placebo (6 puffs administered weekly prior to each NET treatment session for max 16 weeks).
- Primary outcomePrimary study endpoint is the PTSD symptom level. PTSD symptoms will be assessed by means of clinical diagnostic interview (Clinician-Administered PTSD Scale, assessed before the first session and at 1-3 and 14-6 weeks post-treatment) and self-report questionnaire (Impact of Events Scale-Revised, measured at all assessment points).
- Secondary outcomeSecondary study endpoints are measures of stress-reactivity, both self-reported (Perceived Stress Reactivity scale, assessed before the first session and at 1-3 and 14-6 weeks post-treatment) and physiological stress reactivity (heart rate, heart rate variability and salivary cortisol, assessed after each NET session). In addition, co-morbid depressive symptoms are a secondary endpoint. Depressive symptoms will be assessed by self-report questionnaire (Beck Depression Inventory, assessed before the first session and at 1-3 and 14-16 weeks post-treatment).
- TimepointsAssessment with clinical interviews en questionnaires takes place before the first session and at 1-3 and 14-6 weeks post-treatment. Questionnaires and biological measures are performed weekly, for 16 weeks max.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD. Mirjam Zuiden, van
- CONTACT for SCIENTIFIC QUERIESPhD. Mirjam Zuiden, van
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD28-nov-2012 - 6-dec-2012


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