Oxytocin
Drug40 IU oxytocin nasal spray, self-administered
Other names: Pitocin
NCT Number: NCT03238924
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 2
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
40 IU oxytocin nasal spray, self-administered
Other names: Pitocin
Saline nasal spray, self-administered
Time frame: 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.
Time frame: 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.
Time frame: 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.
Medical University of South Carolina
Other
Augmenting Prolonged Exposure Therapy for PTSD With Intranasal Oxytocin
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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