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Intranasal Insulin for Posttraumatic Stress Disorder

Primary Purpose

PTSD

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intranasal insulin
Placebo
Sponsored by
VA Connecticut Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring Intranasal insulin, PTSD

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Connecticut Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intranasal insulin

Placebo

Arm Description

Subjects in this arm will receive 40 IU of intranasal insulin twice a day (80 IU per day).

Subjects in this arm will receive placebo.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
August 1, 2019
Last Updated
April 24, 2023
Sponsor
VA Connecticut Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT04044534
Brief Title
Intranasal Insulin for Posttraumatic Stress Disorder
Official Title
Intranasal Insulin for Treating Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Connecticut Healthcare System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
Intranasal insulin, PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intranasal insulin
Arm Type
Experimental
Arm Description
Subjects in this arm will receive 40 IU of intranasal insulin twice a day (80 IU per day).
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Subjects in this arm will receive placebo.
Intervention Type
Drug
Intervention Name(s)
Intranasal insulin
Intervention Description
Subjects in this arm will receive intranasal insulin (80 IU per day).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects in this arm will receive placebo.
Primary Outcome Measure Information:
Title
Post-traumatic stress disorder (PTSD) symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Description
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 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gihyun Yoon, MD
Phone
(203) 932-5711
Ext
7421
Email
gihyun.yoon@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gihyun Yoon, MD
Organizational Affiliation
VA Connecticut Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gihyun Yoon, MD
Phone
203-932-5711
Ext
7421
Email
gihyun.yoon@yale.edu

12. IPD Sharing Statement

Learn more about this trial

Intranasal Insulin for Posttraumatic Stress Disorder

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