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| ID | Type | Description | Link |
|---|---|---|---|
| CORRC tracking number: 4-2006 |
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The purpose of the study is to find out how a small dose of insulin might affect memory, the ability to concentrate, and improve your daily functioning in patients with schizophrenia and schizoaffective disorders. Insulin is not being used to treat diabetes in this study. The investigators propose a single dose, double-blinded, placebo-controlled trial of intranasal insulin in 40 subjects with schizophrenia or schizoaffective disorder to examine insulin's effect on cognition. The specific aims include:
Insulin will be delivered through an air spray pump into your nose. The investigators will be comparing one dose of insulin (40 International Units) with placebo, an inactive liquid.
Insulin signaling in the brain is associated with improved cognitive function in both animal and human studies. Intranasal administration of insulin, which is non-invasive and minimizes the risk of hypoglycemia, may represent a new intervention approach with the potential to improve cognition and real life functioning in this patient with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (1) | Placebo Comparator | Subjects are given a one-time, single dose of placebo intranasal spray |
|
| Single-Dose Intranasal Insulin | Experimental | Subjects are given a one-time, single dose of intranasal insulin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| Insulin (Humulin) |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Cognitive Function- HVLT Immediate Recall Total (Number) | 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. | pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration |
| Improvement in Cognitive Function- HVLT-Delayed Recall (Number) | 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. | pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration |
| CPT d Score | 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. | pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoduo Fan, MD, MPH, MS | UMass Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Freedom Trail Clinic | Boston | Massachusetts | 02114 | United States |
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.
Subjects were recruited from an urban community mental health clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (1) | Subjects are given a one-time, single dose of placebo intranasal spray |
| FG001 | Single-Dose Intranasal Insulin | Subjects are given a one-time, single dose of intranasal insulin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (1) | Subjects are given a one-time, single dose of placebo intranasal spray |
| BG001 | Single-Dose Intranasal Insulin | Subjects are given a one-time, single dose of intranasal insulin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Improvement in Cognitive Function- HVLT Immediate Recall Total (Number) | 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. | 30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group. | Posted | Mean | Standard Deviation | Words successfully recalled | pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration |
|
28 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (1) | Subjects are given a one-time, single dose of placebo intranasal spray |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Goodnow | UMass Medical School | 508-856-2494 | matthew.goodnow@umassmed.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D061386 | Insulin, Regular, Human |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
40 IU Intranasal Insulin will be administered once |
|
|
| Improvement in Cognitive Function- CPT Hits Rate (Proportion) | 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. | pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration |
| Improvement in Cognitive Function- CPT Reaction Time of Hits (Milliseconds) | 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. | pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration |
| Improvement in Cognitive Function- CPT False Alarm Rate (Proportion) | 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. | pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Single-Dose Intranasal Insulin | Subjects are given a one-time, single dose of intranasal insulin |
|
|
| Primary | Improvement in Cognitive Function- HVLT-Delayed Recall (Number) | 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. | 30 subjects were analyzed in this study. Subjects were randomized to either the experimental or placebo group. | Posted | Mean | Standard Deviation | Words successfully recalled | pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration |
|
|
|
| Primary | CPT d Score | 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. | 30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group. | Posted | Mean | Standard Deviation | units on a scale | pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration |
|
|
|
| Primary | Improvement in Cognitive Function- CPT Hits Rate (Proportion) | 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. | 30 subjects were analyzed. Subjects were randomized either to the experimental or placebo group. | Posted | Mean | Standard Deviation | Proportion of overall attempts | pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration |
|
|
|
| Primary | Improvement in Cognitive Function- CPT Reaction Time of Hits (Milliseconds) | 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. | 30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group. | Posted | Mean | Standard Deviation | Milliseconds | pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration |
|
|
|
| Primary | Improvement in Cognitive Function- CPT False Alarm Rate (Proportion) | 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. | 30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group. | Posted | Mean | Standard Deviation | Proportion of overall attempts | pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Single-Dose Intranasal Insulin | Subjects are given a one-time, single dose of intranasal insulin | 0 | 15 | 0 | 15 |
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |