Prolonged Exposure and Oxytocin

• Oxytocin (Drug), also known as Pitocin: 40 IU oxytocin nasal spray, self-administered
• Placebos (Drug): Saline nasal spray, self-administered

Primary outcomes

• PTSD Symptom Severity [Change from Baseline to end of treatment (10 weeks)]: 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.

Secondary outcomes

• PTSD Symptom Severity [Change from Baseline to end of treatment (10 weeks)]: 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.
• Depression Symptom Severity [Change from Baseline to end of treatment (10 weeks)]: 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.

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

1. Male or female; any race or ethnicity; age 18-75 years.
2. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments.
3. Participants must be able to comprehend English.
4. Meet DSM-5 criteria for current PTSD (assessed via the Clinician Administered PTSD Scale; CAPS).
5. A CAPS score of 50 or greater.
6. 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.
7. 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:

1. 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.
2. 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.
3. Participants on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 8 weeks.
4. Participants meeting DSM-5 criteria for a substance use disorder, except caffeine or nicotine, within the past 12 months.
5. Pregnant women will be excluded from the proposed study.

Participant flow

Outcome results

• PTSD Symptom Severity (Primary), Mean, scores on a scale: Oxytocin 13.00 +/- 12.74; Placebo 17.71 +/- 9.62
• PTSD Symptom Severity (Secondary), Mean, scores on a scale: Oxytocin 20.50 +/- 19.53; Placebo 29.71 +/- 26.39
• Depression Symptom Severity (Secondary), Mean, scores on a scale: Oxytocin 12.67 +/- 11.24; Placebo 17.14 +/- 17.56

Adverse events

Time frame: 2 years.

Other adverse events by term

• Results publication: Flanagan JC, Sippel LM, Wahlquist A, Moran-Santa Maria MM, Back SE. Augmenting Prolonged Exposure therapy for PTSD with intranasal oxytocin: A randomized, placebo-controlled pilot trial. J Psychiatr Res. 2018 Mar;98:64-69. doi: 10.1016/j.jpsychires.2017.12.014. Epub 2017 Dec 26. PMID 29294429