Trial Outcomes & Findings for Effect of Single Dose Intranasal Insulin On Cognitive Function (NCT NCT00646581)
NCT ID: NCT00646581
Last Updated: 2013-02-15
Results Overview
Subjects performed the HVLT Immediate Recall Task. For this task, participants were read aloud a list of 12 words from three taxonomic categories. Participants were read the list three separate times, and after each reading were immediately asked to recall as many words from the list as they could. The number of words recalled successfully was measured before and after intranasal treatment. Values below represent posttreatment performance minus pretreatment performance.
COMPLETED
PHASE4
30 participants
pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
2013-02-15
Participant Flow
Subjects were recruited from an urban community mental health clinic.
Subjects who met DSM-IV criteria for schizophrenia or schizoaffective disorder were enrolled in the study (see inclusion/exclusion criteria). Subjects were randomly assigned to either the experimental group or placebo group.
Participant milestones
| Measure |
Placebo (1)
Subjects are given a one-time, single dose of placebo intranasal spray
|
Single-Dose Intranasal Insulin
Subjects are given a one-time, single dose of intranasal insulin
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Single Dose Intranasal Insulin On Cognitive Function
Baseline characteristics by cohort
| Measure |
Placebo (1)
n=15 Participants
Subjects are given a one-time, single dose of placebo intranasal spray
|
Single-Dose Intranasal Insulin
n=15 Participants
Subjects are given a one-time, single dose of intranasal insulin
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administrationPopulation: 30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.
Subjects performed the HVLT Immediate Recall Task. For this task, participants were read aloud a list of 12 words from three taxonomic categories. Participants were read the list three separate times, and after each reading were immediately asked to recall as many words from the list as they could. The number of words recalled successfully was measured before and after intranasal treatment. Values below represent posttreatment performance minus pretreatment performance.
Outcome measures
| Measure |
Placebo (1)
n=15 Participants
Subjects are given a one-time, single dose of placebo intranasal spray
|
Single-Dose Intranasal Insulin
n=15 Participants
Subjects are given a one-time, single dose of intranasal insulin
|
|---|---|---|
|
Improvement in Cognitive Function- HVLT Immediate Recall Total (Number)
|
4.9 Words successfully recalled
Standard Deviation 2.4
|
5.3 Words successfully recalled
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administrationPopulation: 30 subjects were analyzed in this study. Subjects were randomized to either the experimental or placebo group.
Subjects performed the HVLT word recall task after a 20-minute delay before and after intranasal treatment. In the HVLT delayed recall task, participants were asked to recall the same list of 12 words dictated in the immediate recall task 20 minutes after the completion of the immediate recall task. Words successfully recalled after the 20-minute delay were measured. Values below represent posttreatment performance minus pretreatment performance.
Outcome measures
| Measure |
Placebo (1)
n=15 Participants
Subjects are given a one-time, single dose of placebo intranasal spray
|
Single-Dose Intranasal Insulin
n=15 Participants
Subjects are given a one-time, single dose of intranasal insulin
|
|---|---|---|
|
Improvement in Cognitive Function- HVLT-Delayed Recall (Number)
|
1.1 Words successfully recalled
Standard Deviation 1.8
|
1.4 Words successfully recalled
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administrationPopulation: 30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.
Subjects performed a computer-based test designed to measure sustained attention (attention to a specific stimuli over a period of several minutes) before and after intranasal treatment. During this test, participants respond as quickly as possible to any consecutive presentation of identical stimuli on the computer screen. The stimuli (2, 3, and 4-digit targets) were presented with increasing cognitive load in successive blocks. Correct responses, responses made to the second of 2 identical stimuli presented in a row, were scored as hits. False alarms were also recorded. The "d prime score" is a score given to each participant on a scale of 0.0- 1.0 in which discrimination sensitivity is measured. A score of zero equates to no sensitivity, whereas a score of 1.0 equates to perfect sensitivity. Values below represent postreatment performance minus pretreatment performance.
Outcome measures
| Measure |
Placebo (1)
n=15 Participants
Subjects are given a one-time, single dose of placebo intranasal spray
|
Single-Dose Intranasal Insulin
n=15 Participants
Subjects are given a one-time, single dose of intranasal insulin
|
|---|---|---|
|
CPT d Score
|
0.12 units on a scale
Standard Deviation 0.55
|
0.29 units on a scale
Standard Deviation 0.39
|
PRIMARY outcome
Timeframe: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administrationPopulation: 30 subjects were analyzed. Subjects were randomized either to the experimental or placebo group.
Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in the previous outcome measure ("CPT d score"). Hits rate refers to each participant's ability to correctly respond to two consecutive target presentations (i.e. correct responses). Hits rate was measured as a proportion of overall attempts (0= no hits, 1.0= 100% accuracy on hits). Values below represent posttreatment performance minus pretreatment performance.
Outcome measures
| Measure |
Placebo (1)
n=15 Participants
Subjects are given a one-time, single dose of placebo intranasal spray
|
Single-Dose Intranasal Insulin
n=15 Participants
Subjects are given a one-time, single dose of intranasal insulin
|
|---|---|---|
|
Improvement in Cognitive Function- CPT Hits Rate (Proportion)
|
0.03 Proportion of overall attempts
Standard Deviation 0.15
|
0.09 Proportion of overall attempts
Standard Deviation 0.14
|
PRIMARY outcome
Timeframe: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administrationPopulation: 30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.
Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in detail in a previous outcome measure ("CPT d score"). Reaction time of hits refers to the average time each participant took to correctly respond to a stimuli in milliseconds. Values below represent posttreatment performance minus pretreatment performance.
Outcome measures
| Measure |
Placebo (1)
n=15 Participants
Subjects are given a one-time, single dose of placebo intranasal spray
|
Single-Dose Intranasal Insulin
n=15 Participants
Subjects are given a one-time, single dose of intranasal insulin
|
|---|---|---|
|
Improvement in Cognitive Function- CPT Reaction Time of Hits (Milliseconds)
|
8.5 Milliseconds
Standard Deviation 64.1
|
-13.8 Milliseconds
Standard Deviation 82.9
|
PRIMARY outcome
Timeframe: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administrationPopulation: 30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.
Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in detail in a previous outcome measure ("CPT d score"). False alarm rate refers to the proportion of overall attempts that were characterized as incorrect responses (responses to two non-identical targets). Values below represent posttreatment performance minus pretreatment performance.
Outcome measures
| Measure |
Placebo (1)
n=15 Participants
Subjects are given a one-time, single dose of placebo intranasal spray
|
Single-Dose Intranasal Insulin
n=15 Participants
Subjects are given a one-time, single dose of intranasal insulin
|
|---|---|---|
|
Improvement in Cognitive Function- CPT False Alarm Rate (Proportion)
|
-0.03 Proportion of overall attempts
Standard Deviation 0.10
|
0.02 Proportion of overall attempts
Standard Deviation 0.05
|
Adverse Events
Placebo (1)
Single-Dose Intranasal Insulin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place