PTSD
Conditions
Keywords
Intranasal insulin, PTSD
Brief summary
To evaluate if intranasal insulin is effective in reducing PTSD symptoms.
Detailed description
The current proposal aims to study the pharmacotherapeutic effects of intranasal insulin on PTSD symptoms and inhibition of amygdala hyperactivation in subjects with PTSD.
Interventions
DRUGIntranasal insulin
Subjects in this arm will receive intranasal insulin (80 IU per day).
DRUGPlacebo
Subjects in this arm will receive placebo.
Sponsors
VA Connecticut Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, 21-65 years old * Current PTSD * Able to provide written informed consent
Exclusion criteria
* Unstable medical condition, clinically determined by a physician * Diabetes requiring insulin or oral hypoglycemic agents * Moderate-severe traumatic brain injury * Current psychotic disorder, bipolar disorder, cognitive disorder in the past 12 months * Current substance use disorders (except alcohol, tobacco, or cannabis) in the past 3 months * Changes in doses of psychotropic medications in the past 4 weeks * Initiation of individual therapy or counseling in the past 4 weeks * Imminent suicidal or homicidal risk * Contraindication to Insulin * History of claustrophobia * Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI safety screening questionnaire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD Symptoms on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) From Pre- to Post-Intervention | 1 week | The five-point CAPS-5 consists of 20 PTSD symptoms rated on a 0-4 scale (total range: 0-80) as follows: (1) 5 Intrusion symptoms (0-20), (2) 2 Avoidance symptoms (0-8), (3) 7 Cognitions and mood symptoms (0-28), and (4) 6 Arousal and reactivity symptoms (0-24). Higher scores represent a worse outcome (i.e., more PTSD symptoms). Findings are reported as change scores. For the medication group: CAPS score changes = CAPS score after taking medication for 1 week - CAPS score just before taking medication. For the placebo group: CAPS score changes = CAPS score after taking placebo for 1 week - CAPS score just before taking placebo. A negative value indicates a reduction in symptom severity. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGihyun Yoon, MD
VA Connecticut Healthcare System
Participant flow
Pre-assignment details
Four subjects were withdrawn from the study prior to receiving any study medications.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 38.83 years STANDARD_DEVIATION 5.6 |
| Race/Ethnicity, Customized Latino | 1 Participants |
| Race/Ethnicity, Customized White | 5 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 5 / 6 | 5 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
None listed