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| Name | Class |
|---|---|
| National Alliance for Research on Schizophrenia and Depression | OTHER |
| Eli Lilly and Company | INDUSTRY |
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This study is an 8-week, randomized, double-blind, placebo-controlled trial of intranasal insulin as an adjunctive therapy, with a 4-week follow-up, in 60 non-diabetic schizophrenia subjects to examine insulin's effect on psychopathology and cognition. In addition, the study will examine insulin's effects on weight, food intake, resting energy expenditure, and body composition.
The specific aims include:
Primary aims
Secondary aims
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Intranasal Insulin Treatment |
|
| B | Placebo Comparator | Drug: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin or Placebo | Drug | intranasal, 40IU, 4 times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Function- Digit Span Total | Subjects completed the digit span task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 30. Week 8 values are displayed below. | Week 8 |
| Cognitive Function- Verbal Fluency | Subjects completed a verbal fluency test. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher levels of verbal fluency, and therefore less advanced psychopathology. Min score= 0, Max score= N/A. Week 8 values are displayed below. | Week 8 |
| Cognitive Function- HVLT Immediate Recall Total | Subjects completed a word recall task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 36. Week 8 values are displayed below. | Week 8 |
| Cognitive Function- HVLT Delayed Recall Total | Subjects completed a delayed word recall task. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 12. Week 8 values are displayed below. | Week 8 |
| Cognitive Function- Trails A | Subjects completed a timed "trails" (i.e. connect-the-dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were measured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below. | Week 8 |
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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 |
|---|---|---|---|---|---|---|
| University of Massachusetts Medical School | Worcester | Massachusetts | 01605 | United States |
After providing written informed consent, subjects underwent a diagnostic evaluation by a research psychiatrist using the Structured Clinical Interview for DSM-IV (SCID). All subjects were screened and enrolled based on eligibility criteria. Baseline study assessments were completed prior to intervention.
Subjects were recruited from the Freedom Trail Clinic at the Erich Lindemann Mental Health Center and were studied at the Massachusetts General Hospital Clinical Research Center (MGH CRC), Boston.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention: Insulin | Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up |
| FG001 | Intervention: Placebo | Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention: Insulin | Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up |
| BG001 | Intervention: Placebo | Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up |
| 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 | Cognitive Function- Digit Span Total | Subjects completed the digit span task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 30. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | Items correct | Week 8 |
|
Data was monitored for potential SAEs and AEs for a period of 34 months. For each individual subject, the timeframe for SAE and AE reporting was 12 weeks.
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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 | Intervention: Insulin | Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xiaoduo Fan, MD, MPH, MS | UMass Medical School | 508-856-3881 | Xiaoduo.Fan@umassmed.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Cognitive Function- Trails B |
Subjects completed a timed "trails" (i.e. connect the dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were mesured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below. |
| Week 8 |
| Cognitive Function- CPT D Prime Score | Subjects completed a computer-based cognitive test designed to measure sustained attention (attention to a specific stimulus 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. Higher scores represent less advanced psychopathology. Week 8 values are displayed below. | Week 8 |
| Cognitive Function- CPT Hits Rate (Proportion) | Subjects completed a computer-based cognitive test. The test is described in detail in a previous outcome measure ("CPT d prime score"). Hits rate was defined as the proportion of correct responses to the relevant stimuli (response to two identical targets) compared to total responses (total hits). Assessments were completed at Screening/Baseline, Week 4, and Week 8. Hits rate as a proportion of total hits was measured. Min score= 0, Max score= 1.0. Higher values represent higher stimulus recognition accuracy, and thus less advanced psychopathology. Week 8 values are displayed below. | Week 8 |
| Cognitive Function- CPT Reaction Time of Hits (Milliseconds) | Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). The test is described in detail in a previous outcome measure ("CPT d prime score"). Reaction time of hits is defined as the average time each participant took to respond correctly to relevant stimuli. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Reaction time was measured in milliseconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below. | Week 8 |
| Cognitive Function- CPT False-alarm Rate (Proportion) | Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). False alarm rate is defined as the proportion of overall hits that were in response to an incorrect stimulus (two consecutive non-identical targets). Assessments were completed at Screening/Baseline, Week 4, and Week 8. False-alarm hits were measured as a proportion of total hits. Min score= 0, Max score= 1.0. Lower values represent higher hit accuracy and less advanced psychopathology. Week 8 values are displayed below. | Week 8 |
| Psychopathology- PANSS Total | Positive symptoms, negative symptoms, and general psychopatholgy of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 30 total items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 30, Max score= 210. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. | Week 8 |
| Psychopathology- PANSS Positive | Positive symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of seven items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. | Week 8 |
| Psychopathology- PANSS Negative | Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of seven-items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. | Week 8 |
| Psychopathology- PANSS General Psychopathology | General psychopathology was measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 16 items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 16, Max score= 112. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. | Week 8 |
| Psychopathology- SANS Total | Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 25 items, with each item measured on a six-point scale (0= none, 3= moderate, 5= severe). Min score= 0, Max score= 125. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. | Week 8 |
| Psychopathology- CDSS Total | Symptoms of depression were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 9 items, with each item measured on a four-point scale (0= absent, 3= severe). Min score= 0, Max score= 27. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. | Week 8 |
| Psychopathology- QLS Total | Quality of life was measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 21 items, with each item measured on a seven-point scale (0= not present, 3= sometimes present, 6= always present). Min score= 0, Max score= 126. Higher scores represent lower quality of life. Week 8 values are displayed below. | Week 8 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Cognitive Function- Verbal Fluency | Subjects completed a verbal fluency test. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher levels of verbal fluency, and therefore less advanced psychopathology. Min score= 0, Max score= N/A. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | Words correct | Week 8 |
|
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|
| Primary | Cognitive Function- HVLT Immediate Recall Total | Subjects completed a word recall task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 36. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | Words correct | Week 8 |
|
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|
| Primary | Cognitive Function- HVLT Delayed Recall Total | Subjects completed a delayed word recall task. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 12. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | Words correct | Week 8 |
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| Primary | Cognitive Function- Trails A | Subjects completed a timed "trails" (i.e. connect-the-dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were measured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | Seconds | Week 8 |
|
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|
| Primary | Cognitive Function- Trails B | Subjects completed a timed "trails" (i.e. connect the dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were mesured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | Seconds | Week 8 |
|
|
|
| Primary | Cognitive Function- CPT D Prime Score | Subjects completed a computer-based cognitive test designed to measure sustained attention (attention to a specific stimulus 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. Higher scores represent less advanced psychopathology. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | D prime score | Week 8 |
|
|
|
| Primary | Cognitive Function- CPT Hits Rate (Proportion) | Subjects completed a computer-based cognitive test. The test is described in detail in a previous outcome measure ("CPT d prime score"). Hits rate was defined as the proportion of correct responses to the relevant stimuli (response to two identical targets) compared to total responses (total hits). Assessments were completed at Screening/Baseline, Week 4, and Week 8. Hits rate as a proportion of total hits was measured. Min score= 0, Max score= 1.0. Higher values represent higher stimulus recognition accuracy, and thus less advanced psychopathology. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | Proportion of total hits | Week 8 |
|
|
|
| Primary | Cognitive Function- CPT Reaction Time of Hits (Milliseconds) | Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). The test is described in detail in a previous outcome measure ("CPT d prime score"). Reaction time of hits is defined as the average time each participant took to respond correctly to relevant stimuli. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Reaction time was measured in milliseconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | Milliseconds | Week 8 |
|
|
|
| Primary | Cognitive Function- CPT False-alarm Rate (Proportion) | Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). False alarm rate is defined as the proportion of overall hits that were in response to an incorrect stimulus (two consecutive non-identical targets). Assessments were completed at Screening/Baseline, Week 4, and Week 8. False-alarm hits were measured as a proportion of total hits. Min score= 0, Max score= 1.0. Lower values represent higher hit accuracy and less advanced psychopathology. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | Proportion of total hits | Week 8 |
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|
| Primary | Psychopathology- PANSS Total | Positive symptoms, negative symptoms, and general psychopatholgy of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 30 total items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 30, Max score= 210. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
|
|
|
| Primary | Psychopathology- PANSS Positive | Positive symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of seven items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
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| Primary | Psychopathology- PANSS Negative | Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of seven-items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
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| Primary | Psychopathology- PANSS General Psychopathology | General psychopathology was measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 16 items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 16, Max score= 112. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
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| Primary | Psychopathology- SANS Total | Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 25 items, with each item measured on a six-point scale (0= none, 3= moderate, 5= severe). Min score= 0, Max score= 125. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
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| Primary | Psychopathology- CDSS Total | Symptoms of depression were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 9 items, with each item measured on a four-point scale (0= absent, 3= severe). Min score= 0, Max score= 27. Higher scores represent more advanced psychopathology. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
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| Primary | Psychopathology- QLS Total | Quality of life was measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 21 items, with each item measured on a seven-point scale (0= not present, 3= sometimes present, 6= always present). Min score= 0, Max score= 126. Higher scores represent lower quality of life. Week 8 values are displayed below. | All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores. | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
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| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Intervention: Placebo | Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up | 0 | 24 | 0 | 24 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |