Intranasal Insulin for Posttraumatic Stress Disorder
ConditionPTSD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorVA Connecticut Healthcare System
About this trial
To evaluate if intranasal insulin is effective in reducing PTSD symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, 21-65 years old
Current PTSD
Able to provide written informed consent
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Intranasal insulin
DrugSubjects in this arm will receive intranasal insulin (80 IU per day).
Placebo
DrugSubjects in this arm will receive placebo.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Intranasal insulinExperimental treatment 1 intervention
Group B: PlaceboExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Post-traumatic stress disorder (PTSD) symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
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).
Time frame
1 weekSponsors and contacts
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Source ClinicalTrials.gov