Prolonged Exposure and Oxytocin

NCT03238924 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 36616
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

PTSD

Keywords

posttraumatic stress disorder; oxytocin; Prolonged Exposure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PTSD Symptom Severity

  Change from Baseline to end of treatment (10 weeks)

• Depression Symptom Severity

  Change from Baseline to end of treatment (10 weeks)

Study Arms (2)

Oxytocin

EXPERIMENTAL

40 IU intranasal oxytocin spray

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Placebo is matching saline nasal spray

Drug: Placebos

Interventions

Oxytocin DRUG

40 IU oxytocin nasal spray, self-administered

Also known as: Pitocin

Oxytocin

Placebos DRUG

Saline nasal spray, self-administered

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Julianne Flanagan
• Organization: Medical University of South Carolina

Hellmuth@musc.edu

843-792-5569

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: August 3, 2017
• Study Start: January 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: May 25, 2018
• Results First Posted: May 25, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share