Trial Outcomes & Findings for Prolonged Exposure and Oxytocin (NCT NCT03238924)

Last Updated: 2018-05-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

Change from Baseline to end of treatment (10 weeks)

Results posted on

2018-05-25

Participant Flow

Participant milestones

Participant milestones
Measure	Oxytocin 40 IU intranasal oxytocin spray Oxytocin: 40 IU oxytocin nasal spray, self-administered	Placebo Placebo is matching saline nasal spray Placebos: Saline nasal spray, self-administered
Overall Study STARTED	8	9
Overall Study COMPLETED	6	7
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Oxytocin 40 IU intranasal oxytocin spray Oxytocin: 40 IU oxytocin nasal spray, self-administered	Placebo Placebo is matching saline nasal spray Placebos: Saline nasal spray, self-administered
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

Prolonged Exposure and Oxytocin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxytocin n=8 Participants 40 IU intranasal oxytocin spray Oxytocin: 40 IU oxytocin nasal spray, self-administered	Placebo n=9 Participants Placebo is matching saline nasal spray Placebos: Saline nasal spray, self-administered	Total n=17 Participants Total of all reporting groups
Age, Continuous	41.63 years STANDARD_DEVIATION 14.58 • n=5 Participants	45.78 years STANDARD_DEVIATION 15.09 • n=7 Participants	43.82 years STANDARD_DEVIATION 14.54 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline to end of treatment (10 weeks)

Population: Data belonging to participants who completed the trial were examined.

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.

Outcome measures

Outcome measures
Measure	Oxytocin n=6 Participants 40 IU intranasal oxytocin spray Oxytocin: 40 IU oxytocin nasal spray, self-administered	Placebo n=7 Participants Placebo is matching saline nasal spray Placebos: Saline nasal spray, self-administered
PTSD Symptom Severity	13.00 scores on a scale Standard Deviation 12.74	17.71 scores on a scale Standard Deviation 9.62

SECONDARY outcome

Timeframe: Change from Baseline to end of treatment (10 weeks)

Population: Data belonging to participants who completed the trial were examined.

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.

Outcome measures

Outcome measures
Measure	Oxytocin n=6 Participants 40 IU intranasal oxytocin spray Oxytocin: 40 IU oxytocin nasal spray, self-administered	Placebo n=7 Participants Placebo is matching saline nasal spray Placebos: Saline nasal spray, self-administered
PTSD Symptom Severity	20.50 scores on a scale Standard Deviation 19.53	29.71 scores on a scale Standard Deviation 26.39

SECONDARY outcome

Timeframe: Change from Baseline to end of treatment (10 weeks)

Population: Data belonging to participants who completed the trial were examined.

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.

Outcome measures

Outcome measures
Measure	Oxytocin n=6 Participants 40 IU intranasal oxytocin spray Oxytocin: 40 IU oxytocin nasal spray, self-administered	Placebo n=7 Participants Placebo is matching saline nasal spray Placebos: Saline nasal spray, self-administered
Depression Symptom Severity	12.67 scores on a scale Standard Deviation 11.24	17.14 scores on a scale Standard Deviation 17.56

Adverse Events

Oxytocin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Oxytocin n=8 participants at risk 40 IU intranasal oxytocin spray Oxytocin: 40 IU oxytocin nasal spray, self-administered	Placebo n=9 participants at risk Placebo is matching saline nasal spray Placebos: Saline nasal spray, self-administered
General disorders Chest pain	0.00% 0/8 • 2 years. All adverse events were recorded.	11.1% 1/9 • Number of events 1 • 2 years. All adverse events were recorded.

Additional Information

Dr. Julianne Flanagan

Medical University of South Carolina

Phone: 843-792-5569

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place