Posttraumatic Stress Disorder
Conditions
Keywords
Effect of oxytocin on learning
Brief summary
The purpose of the study is to learn how differences in learning under mildly-stressful circumstances may be changed by taking oxytocin. Oxytocin is a hormone made naturally in the body. The investigators will also examine the impact of any anxiety, depression, and stress related symptoms on learning processes.
Interventions
DRUGOxytocin
Liquid metered-dose nasal spray, 30 IUs, administered once.
DRUGPlacebo
Matched nasal spray placebo
Sponsors
United States Department of Defense
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Men or women 18 to 65 years of age * Score in study range on the Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI) * No current Axis I Diagnostic and Statistical Manual-IV (DSM) excluded diagnoses as determined by the Structured Clinical Interview DSM (SCID) completed within the past 4 months. * Must be able and willing to understand study procedures and return to the clinic on two separate consecutive days for the fear-conditioning procedures. * Subjects must be able to give informed consent and be willing and able to comply with study procedures.
Exclusion criteria
* Presence of a current DSM-IV Axis I diagnosis as measured by the SCID. * A serious medical condition or other condition deemed likely to result in surgery or hospitalization, or which would make participation in the study difficult. * Patients with a history of trauma resulting in head injury related seizures or with epilepsy (except a prior history of febrile seizures of infancy which are not exclusionary). * Use of supplemental hormones (birth control, estrogen, testosterone, prednisone, etc) or narcotics. * Pregnant or lactating women. * Women of childbearing potential not using medically accepted forms of contraception. * Current use of the excluded psychiatric medications. * Known hypersensitivity to oxytocin * Known hyponatremia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differential Skin Conductance Response (SCR) During the First Two Extinction Trials | Day 2 of Conditioning (1 day post Day 1 of Conditioning) | Differences in skin conductance response (SCR) between the active vs. placebo conditions trials will be used to assess for the impact of oxytocin on fear acquisition and extinction. We will take a mean of the first two extinction trials to get this measure. Data was gathered in micro-Siemens and then underwent a square root transformation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matched nasal spray placebo.
Placebo: Matched nasal spray placebo | 16 |
| Oxytocin Liquid intranasal oxytocin administered in a nasal spray.
Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once. | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | Oxytocin | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 16 Participants | 30 Participants |
| Age, Continuous | 39.9 Years STANDARD_DEVIATION 15.8 | 31.9 Years STANDARD_DEVIATION 14.7 | 35.6 Years STANDARD_DEVIATION 15.5 |
| Region of Enrollment United States | 14 participants | 16 participants | 30 participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 16 | 0 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
Primary
Differential Skin Conductance Response (SCR) During the First Two Extinction Trials
Differences in skin conductance response (SCR) between the active vs. placebo conditions trials will be used to assess for the impact of oxytocin on fear acquisition and extinction. We will take a mean of the first two extinction trials to get this measure. Data was gathered in micro-Siemens and then underwent a square root transformation.
Time frame: Day 2 of Conditioning (1 day post Day 1 of Conditioning)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Differential Skin Conductance Response (SCR) During the First Two Extinction Trials | 0.15 micro-Siemens (square rooted) | Standard Deviation 0.31 |
| Oxytocin | Differential Skin Conductance Response (SCR) During the First Two Extinction Trials | 0.00 micro-Siemens (square rooted) | Standard Deviation 0.39 |
p-value: 0.28t-test, 2 sided