Intranasal Insulin for Posttraumatic Stress Disorder
Intranasal Insulin for Treating Posttraumatic Stress Disorder
1 other identifier
interventional
20
1 country
1
Brief Summary
To evaluate if intranasal insulin is effective in reducing PTSD symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2019
CompletedFirst Posted
Study publicly available on registry
August 5, 2019
CompletedStudy Start
First participant enrolled
October 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
September 16, 2025
September 1, 2025
1.6 years
August 1, 2019
September 15, 2025
Conditions
Keywords
Outcome Measures
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).
1 week
Study Arms (2)
Intranasal insulin
EXPERIMENTALSubjects in this arm will receive 40 IU of intranasal insulin twice a day (80 IU per day).
Placebo
EXPERIMENTALSubjects in this arm will receive placebo.
Interventions
Subjects in this arm will receive intranasal insulin (80 IU per day).
Eligibility Criteria
You may qualify if:
- Male or female, 21-65 years old
- Current PTSD
- Able to provide written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gihyun Yoon, MD
VA Connecticut Healthcare System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 1, 2019
First Posted
August 5, 2019
Study Start
October 31, 2024
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
September 16, 2025
Record last verified: 2025-09