Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2024-10-31
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Intranasal insulin
Subjects in this arm will receive 40 IU of intranasal insulin twice a day (80 IU per day).
Intranasal insulin
Subjects in this arm will receive intranasal insulin (80 IU per day).
Placebo
Subjects in this arm will receive placebo.
Placebo
Subjects in this arm will receive placebo.
Interventions
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Intranasal insulin
Subjects in this arm will receive intranasal insulin (80 IU per day).
Placebo
Subjects in this arm will receive placebo.
Eligibility Criteria
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Inclusion Criteria
* Current PTSD
* Able to provide written informed consent
Exclusion Criteria
* 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
21 Years
65 Years
ALL
No
Sponsors
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VA Connecticut Healthcare System
FED
Responsible Party
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Gihyun Yoon, MD
Principal Investigator
Principal Investigators
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Gihyun Yoon, MD
Role: PRINCIPAL_INVESTIGATOR
VA Connecticut Healthcare System
Locations
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VA Connecticut Healthcare System
West Haven, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GY0005
Identifier Type: -
Identifier Source: org_study_id
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