Primary outcomeMean· Change from Baseline to end of treatment (10 weeks)
PTSD Symptom Severity
| Group | Value (scores on a scale) | Spread |
|---|---|---|
| Oxytocin | 13.00 | 12.74 |
| Placebo | 17.71 | 9.62 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataProlonged Exposure and Oxytocin
NCTNCT03238924 (opens ClinicalTrials.gov in a new tab)Other id36616
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 17 participants (actual)
- Sponsor
- Medical University of South Carolina · Other
- Design
- Randomized · Quadruple masking
- Countries
- Not stated
- Start
- 1 Jan 2015
- Primary completion
- 31 Dec 2016
- Completion
- 31 Dec 2016
- First posted
- 3 Aug 2017
- Last update posted
- 25 May 2018
- Conditions
- PTSD
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201520162017
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- OxytocinDrug
- PlacebosDrug
Arms2
Experimental
Oxytocin
40 IU intranasal oxytocin spray
Placebo comparator
Placebo
Placebo is matching saline nasal spray
Primary outcomes1
Outcomes the sponsor listed as primary.
PTSD Symptom Severity
Time frame · Change from Baseline to end of treatment (10 weeks)
Registry description
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(2)
PTSD Symptom Severity
Time frame · Change from Baseline to end of treatment (10 weeks)
Registry description
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
Time frame · Change from Baseline to end of treatment (10 weeks)
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcomeMean· Change from Baseline to end of treatment (10 weeks)
PTSD Symptom Severity
| Group | Value (scores on a scale) | Spread |
|---|---|---|
| Oxytocin | 20.50 | 19.53 |
| Placebo | 29.71 | 26.39 |
Secondary outcomeMean· Change from Baseline to end of treatment (10 weeks)
Depression Symptom Severity
| Group | Value (scores on a scale) | Spread |
|---|---|---|
| Oxytocin | 12.67 | 11.24 |
| Placebo | 17.14 | 17.56 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Oxytocin40 IU intranasal oxytocin spray Oxytocin: 40 IU oxytocin nasal spray, self-administered | 0 / 8 | 0 / 8 | 0 / 8 |
| PlaceboPlacebo is matching saline nasal spray Placebos: Saline nasal spray, self-administered | 0 / 9 | 0 / 9 | 1 / 9 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2018
4 results
Augmenting Prolonged Exposure therapy for PTSD with intranasal oxytocin: A randomized, placebo-controlled pilot trial.
Flanagan et al. 2018Journal of psychiatric researchcited by 83
PMID 29294429PMC5800951DOI 10.1016/j.jpsychires.2017.12.014PUB-29294429
Rights unknown4 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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