Trial Outcomes & Findings for Intranasal Insulin for Posttraumatic Stress Disorder (NCT NCT04044534)
NCT ID: NCT04044534
Last Updated: 2026-07-13
Results Overview
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.
COMPLETED
PHASE2
10 participants
1 week
2026-07-13
Participant Flow
Four subjects were withdrawn from the study prior to receiving any study medications.
Participant milestones
| Measure |
All Participants (Crossover)
Subjects will be randomly assigned to one of two treatment conditions (A or B). Subjects will take either 40 IU of insulin twice a day (80 IU per day) or placebo for one week for each drug, separated by a washout period (study drug free period) for 1 week
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|---|---|
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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6
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Consolidated baseline characteristics for the 6 participants who completed the crossover study.
Baseline characteristics by cohort
| Measure |
All Participants (Crossover)
n=6 Participants
Subjects with PTSD will be randomly assigned to one of two treatment conditions (A or B). Subjects will take either 40 IU of insulin twice a day (80 IU per day) or placebo for one week for each drug, separated by a washout period (study drug free period) for 1 week
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|---|---|
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Age, Continuous
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38.83 years
STANDARD_DEVIATION 5.60 • n=20 Participants • Consolidated baseline characteristics for the 6 participants who completed the crossover study.
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Sex: Female, Male
Female
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5 Participants
n=20 Participants • Consolidated baseline characteristics for the 6 participants who completed the crossover study.
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Sex: Female, Male
Male
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1 Participants
n=20 Participants • Consolidated baseline characteristics for the 6 participants who completed the crossover study.
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Race/Ethnicity, Customized
Latino
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1 Participants
n=20 Participants • Consolidated baseline characteristics for the 6 participants who completed the crossover study.
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Race/Ethnicity, Customized
White
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5 Participants
n=20 Participants • Consolidated baseline characteristics for the 6 participants who completed the crossover study.
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PRIMARY outcome
Timeframe: 1 weekThe 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.
Outcome measures
| Measure |
Intranasal Insulin
n=6 Participants
Subjects will be randomly assigned to one of two treatment conditions (A or B). Subjects will take either 40 IU of insulin twice a day (80 IU per day) or placebo for one week for each drug, separated by a washout period (study drug free period) for 1 week.
|
Placebo
n=6 Participants
Subjects will be randomly assigned to one of two treatment conditions (A or B). Subjects will take either 40 IU of insulin twice a day (80 IU per day) or placebo for one week for each drug, separated by a washout period (study drug free period) for 1 week
|
|---|---|---|
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Change in PTSD Symptoms on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) From Pre- to Post-Intervention
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-7.33 score on a scale
Standard Deviation 12.08
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-7.00 score on a scale
Standard Deviation 9.21
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Adverse Events
Intranasal Insulin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intranasal Insulin
n=6 participants at risk
Subjects will be randomly assigned to one of two treatment conditions (A or B). Subjects will take either 40 IU of insulin twice a day (80 IU per day) or placebo for one week for each drug, separated by a washout period (study drug free period) for 1 week.
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Placebo
n=6 participants at risk
Subjects will be randomly assigned to one of two treatment conditions (A or B). Subjects will take either 40 IU of insulin twice a day (80 IU per day) or placebo for one week for each drug, separated by a washout period (study drug free period) for 1 week
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|---|---|---|
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Nervous system disorders
Drowsiness
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66.7%
4/6 • 1 week per intervention phase
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33.3%
2/6 • 1 week per intervention phase
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Nervous system disorders
Headache
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50.0%
3/6 • 1 week per intervention phase
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83.3%
5/6 • 1 week per intervention phase
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Psychiatric disorders
Confusion
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50.0%
3/6 • 1 week per intervention phase
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33.3%
2/6 • 1 week per intervention phase
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Respiratory, thoracic and mediastinal disorders
Sneezing
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50.0%
3/6 • 1 week per intervention phase
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16.7%
1/6 • 1 week per intervention phase
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|
Skin and subcutaneous tissue disorders
Excessive Perspiration
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16.7%
1/6 • 1 week per intervention phase
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33.3%
2/6 • 1 week per intervention phase
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|
General disorders
Other
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33.3%
2/6 • 1 week per intervention phase
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0.00%
0/6 • 1 week per intervention phase
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place