Posttraumatic stress disorder MedDRA version: 14.1 Level: PT Classification code 10036316 Term: Post-traumatic stress disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Syntocinon, nasal spray 40 IU/ml
Pharmaceutical Form: Nasal drops, solution
Pharmaceutical form of the placebo: Nasal spray, solution
Route of administration of the placebo: Intranasal use
Sponsors
Academic Medical Center, University of Amsterdam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with a diagnosis of chronic PTSD (> 3 months) -CAPS score of 50 -Age 18-65 years -Written informed consent 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 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Suicidal risk. - 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. - Female patients being pregnant (NB. female patients with childbearing potential must have a negative pregnancy test each month). - Female patients with an active pregnancy wish. - Female patients giving lactation to their child. - Diagnosis of current severe depressive disorder (with psychotic features and/or high suicidal intent). - An organic disorder/cognitive impairment. - 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. -Use of prostaglandins and certain anti-migraine medications (ergot alkaloids), systemic glucocorticoids and beta-blockers. -Sensitivity or allergy for oxytocin or its components (e.g. methylhydroxybenzoaat en propylhydroxybenzoaat) -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the effectiveness of the administration of intranasal oxytocin in addition to Narrative Exposure therapy (NET) in reducing PTSD and co-morbid depressive symptoms in patients with chronic PTSD, compared to administration of placebo. We hypothesize that both groups will show a reduction in PTSD and depressive symptoms over the course of the treatment, but that the reduction in symptoms will be faster and larger in the oxytocin group.;Secondary Objective: The secondary objective is to investigate whether administration of intranasal oxytocin in addition to Narrative Exposure therapy (NET) is more effective in dampening stress reactivity in patients with chronic PTSD, compared to administration of placebo. We hypothesize that both groups will show a dampening of both self-reported and physiological stress-reactivity (heart rate, heart rate variability, salivary cortisol), but that the dampening of stress reactivity will be faster and larger in the oxytocin group.;Primary end point(s): Primary study endpoints are levels of PTSD and co-morbid depressive symptoms. PTSD symptoms will be assessed by means of clinical diagnostic interviews (Clinician-Administered PTSD Scale, assessed before the first session and at 1-3 and 14-6 weeks after the final NET session) and self-report questionnaires (Impact of Events Scale-Revised, measured at all assessment points). Depressive symptoms will be assessed by self-report questionnaire (Beck Depression Inventory, assessed before the first session and at 1-3 and 14-6 weeks after the final NET session). ;Timepoint(s) of evaluation of this end point: After each NET session, and 1-3 and 14-16 weeks after the final NET session | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary 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 after the final NET session) and physiological stress reactivity (heart rate, heart rate variability and salivary cortisol, assessed after each NET session).;Timepoint(s) of evaluation of this end point: After each NET session, and at 1-3 and 14-16 weeks after the final NET session | — |
Countries
Netherlands
Contacts
Public ContactOlff- Oxytocin research group
Academic Medical Center, University of Amsterdam
Outcome results
None listed