Prolonged Exposure and Oxytocin

Study Overview
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Brief Summary
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Posttraumatic stress disorder (PTSD) is a chronic, debilitating anxiety disorder that may develop after direct or indirect exposure to traumatic events. Prolonged Exposure (PE) is a cognitive-behavioral psychotherapy modality with a wealth of empirical support demonstrating its efficacy to treat PTSD in a variety of populations. The neuropeptide oxytocin is a promising new pharmacotherapeutic agent with prominent anxiolytic effects . Despite a strong biological and theoretical rationale for investigating the potential effectiveness of augmenting PE with intranasal oxytocin, no studies to date have done so. The current study aims to address this important gap in the literature by examining changes in PTSD symptoms following PE treatment combined with a) 40 IU of intranasal oxytocin or b) placebo.

Official Title
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Augmenting Prolonged Exposure Therapy for PTSD With Intranasal Oxytocin

Conditions
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PTSD

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female; any race or ethnicity; age 18-75 years. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments. Participants must be able to comprehend English. Meet DSM-5 criteria for current PTSD (assessed via the Clinician Administered PTSD Scale; CAPS). A CAPS score of 50 or greater. Participants may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria) or anxiety disorders (e.g., agoraphobia, social phobia, generalized anxiety disorder). The inclusion of participants with affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with PTSD. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least eight weeks before study initiation. Initiation or change of psychotropic medications during the course of the trial may interfere with interpretation of results. Exclusion Criteria: Participants meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders, or with current suicidal or homicidal ideation and intent. Those participants will be referred clinically. Participants who would present a serious suicide risk or who are likely to require hospitalization during the course of the study. Those participants will be referred clinically. Participants on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 8 weeks. Participants meeting DSM-5 criteria for a substance use disorder, except caffeine or nicotine, within the past 12 months. Pregnant women will be excluded from the proposed study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin<br>40 IU intranasal oxytocin spray | Drug: Oxytocin<br>* 40 IU oxytocin nasal spray, self-administered<br>* Other names: Pitocin;|
| Placebo Comparator: Placebo<br>Placebo is matching saline nasal spray | Drug: Placebos<br>* Saline nasal spray, self-administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Symptom Severity | Clinician-Administered PTSD Scale (CAPS-5). CAPS-5 scores range from 0-120. Items are summed to obtain a total score with higher scores reflective of greater symptom severity. | Change from Baseline to end of treatment (10 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Symptom Severity | PTSD Checklist (PCL). The PCL is a self-report measure which uses a 5-point scale to assess the frequency and severity of PTSD symptoms. Item responses are summed to obtain a total score ranging from 17-85 with greater scores reflective of greater symptom severity. | Change from Baseline to end of treatment (10 weeks) | 
| Depression Symptom Severity | Beck Depression Inventory-II. The BDI-II is a self-report measure where each item is rated on a 0-3 scale and summed to obtain a total score. Greater scores are reflective of greater symptom severity. | Change from Baseline to end of treatment (10 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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posttraumatic stress disorder, oxytocin, Prolonged Exposure