Oxytocin in PTSD: effectiveness as addition to Narrative Exposure Therapy

INTERVENTION: 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 (Noncurrent) CONDITION: Posttraumatic stress disorder ; MedDRA version: 14.1 Level: PT Classification code 10036316 Term: Post‐traumatic stress disorder System Organ Class: 10037175 ‐ Psychiatric disorders Therapeutic area: Psychiatry and Psychology [F] ‐ Mental Disorders [F03] PRIMARY OUTCOME: 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. 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). 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. 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 OUTCOME: 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 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