PTSD
Conditions
Keywords
posttraumatic stress disorder, oxytocin, Prolonged Exposure
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.
Interventions
DRUGOxytocin
40 IU oxytocin nasal spray, self-administered
DRUGPlacebos
Saline nasal spray, self-administered
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxytocin 40 IU intranasal oxytocin spray
Oxytocin: 40 IU oxytocin nasal spray, self-administered | 8 |
| Placebo Placebo is matching saline nasal spray
Placebos: Saline nasal spray, self-administered | 9 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Oxytocin | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 41.63 years STANDARD_DEVIATION 14.58 | 43.82 years STANDARD_DEVIATION 14.54 | 45.78 years STANDARD_DEVIATION 15.09 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 3 Participants |
| Region of Enrollment United States | 8 participants | 17 participants | 9 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 7 Participants | 14 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 |
| other Total, other adverse events | 0 / 8 | 1 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 |
Outcome results
Primary
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.
Time frame: Change from Baseline to end of treatment (10 weeks)
Population: Data belonging to participants who completed the trial were examined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | PTSD Symptom Severity | 13.00 scores on a scale | Standard Deviation 12.74 |
| Placebo | PTSD Symptom Severity | 17.71 scores on a scale | Standard Deviation 9.62 |
Secondary
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.
Time frame: Change from Baseline to end of treatment (10 weeks)
Population: Data belonging to participants who completed the trial were examined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Depression Symptom Severity | 12.67 scores on a scale | Standard Deviation 11.24 |
| Placebo | Depression Symptom Severity | 17.14 scores on a scale | Standard Deviation 17.56 |
Secondary
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.
Time frame: Change from Baseline to end of treatment (10 weeks)
Population: Data belonging to participants who completed the trial were examined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | PTSD Symptom Severity | 20.50 scores on a scale | Standard Deviation 19.53 |
| Placebo | PTSD Symptom Severity | 29.71 scores on a scale | Standard Deviation 26.39 |