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| Name | Class |
|---|---|
| Stanley Medical Research Institute | OTHER |
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This is a 24-week, randomized, double-blind, placebo-controlled trial of exenatide weekly injection (2mg per dose) as an adjunctive therapy in 70 schizophrenia subjects to examine exenatide's effects on negative symptoms and cognition.
The specific aims include:
Primary aim:
1. Examine the efficacy of exenatide weekly injection in improving negative symptoms as measured by the Scale for the Assessment of Negative Symptoms (SANS) total score.
Secondary aims:
1. Examine the efficacy of exenatide in improving cognition as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) composite score.
Tertiary/Exploratory aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Exenatide 2mg subcutaneous injection, once weekly |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | Drug | Exenatide SQ 2mg/week for 24 weeks. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score | SANS measures negative symptoms on a 25-item, six point scale each (0-5; none-severe). Items are listed under five domains including affective flattening or blunting, alogia, avolition/apathy, anhedonia/asociality, and attention. The total possible score ranges from 0 to 125. | Baseline, Week 6, Week 12, Week 18 and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite T-score | The MATRICS Consensus Cognitive Battery (MCCB) measures cognition relevant to schizophrenia and related disorders. The MCCB consists of ten individually administered tests that measure cognitive performance in seven domains including speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The raw scores from the ten tests are entered in the MCCB Computer Scoring Program software, which provides an age and gender-corrected T-score and percentile on the seven cognitive domains. A T-score of 50 +/- 10 represents a normative mean performance in each test. Accordingly, the criterion for assignment to cognitively normal-range group require an overall composite T-score from 40 to 60. These data points from baseline visit to week 24 will measure changes in cognition in addition overall cognitive ability compared to healthy individuals. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoduo Fan, MD, MPH, MS | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Medical School | Worcester | Massachusetts | 01605 | United States |
Subjects who met DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) criteria for schizophrenia or schizoaffective disorder were enrolled in the study (see inclusion/exclusion criteria). Eligible subjects were randomly assigned to either the experimental or placebo group.
Single-site study conducted at University of Massachusetts (UMass) Medical School. Subjects were recruited from UMass Memorial Healthcare facilities and ambulatory clinics in Worcester, MA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | (existing treatment) + (Drug) Intervention: Drug: Exenatide Exenatide: Exenatide 2mg/week subcutaneous injection for 24 weeks. |
| FG001 | Placebo | (existing treatment) + (Placebo) Intervention: Drug: Placebo Placebo: Placebo IM for 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | (existing treatment) + (Drug) Intervention: Drug: Exenatide Exenatide: Exenatide IM 2mg/week for 24 weeks. |
| BG001 | Placebo | (existing treatment) + (Placebo) Intervention: Drug: Placebo Placebo: Placebo IM for 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score | SANS measures negative symptoms on a 25-item, six point scale each (0-5; none-severe). Items are listed under five domains including affective flattening or blunting, alogia, avolition/apathy, anhedonia/asociality, and attention. The total possible score ranges from 0 to 125. | 12 subjects in experimental arm withdrew or were lost to follow-up by week 24. 4 subjects in the experimental arm were removed from study by investigator by week 24. 11 subjects in placebo arm withdrew or were lost to follow-up by week 24. 2 subjects in the placebo arm were removed from study by investigator by week 24. Reasons for removal include inpatient hospitalization, increase in depressive symptoms, elevated HbA1c, starting insulin therapy and repeatedly missing visits. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6, Week 12, Week 18 and Week 24 |
|
24 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 | Experimental | (existing treatment) + (Drug) Intervention: Drug: Exenatide Exenatide: Exenatide IM 2mg/week for 24 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bump at injection site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xiaoduo Fan, MD, MPH | UMass Medical School | (508) 856 -3881 | xiaoduo.fan@umassmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2019 | Nov 30, 2021 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2019 | May 20, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| Placebo | Drug | Placebo SQ 1x/week for 24 weeks. |
|
|
| Baseline, Week 6, Week 12, Week 18, and Week 24. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education | Mean | Standard Deviation | years |
|
| Age of illness onset | Mean | Standard Deviation | years |
|
| Duration of illness | Mean | Standard Deviation | years |
|
| Schizophrenia | Count of Participants | Participants |
|
| Schizoaffective disorder | Count of Participants | Participants |
|
| Typical antipsychotic medication | Count of Participants | Participants |
|
| Atypical antipsychotic medication | Count of Participants | Participants |
|
(existing treatment) + (Drug) Intervention: Drug: Exenatide Exenatide: Exenatide IM 2mg/week for 24 weeks. |
| OG001 | Placebo | (existing treatment) + (Placebo) Intervention: Drug: Placebo Placebo: Placebo IM for 24 weeks. |
|
|
| Secondary | Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite T-score | The MATRICS Consensus Cognitive Battery (MCCB) measures cognition relevant to schizophrenia and related disorders. The MCCB consists of ten individually administered tests that measure cognitive performance in seven domains including speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The raw scores from the ten tests are entered in the MCCB Computer Scoring Program software, which provides an age and gender-corrected T-score and percentile on the seven cognitive domains. A T-score of 50 +/- 10 represents a normative mean performance in each test. Accordingly, the criterion for assignment to cognitively normal-range group require an overall composite T-score from 40 to 60. These data points from baseline visit to week 24 will measure changes in cognition in addition overall cognitive ability compared to healthy individuals. | 12 subjects in experimental arm withdrew or were lost to follow-up by week 24. 4 subjects in the experimental arm were removed from study by investigator by week 24. 11 subjects in placebo arm withdrew or were lost to follow-up by week 24. 2 subjects in the placebo arm were removed from study by investigator by week 24. Reasons for removal include inpatient hospitalization, increase in depressive symptoms, elevated HbA1c, starting insulin and repeatedly missing visits during study period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6, Week 12, Week 18, and Week 24. |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 29 |
| 35 |
| EG001 | Placebo | (existing treatment) + (Placebo) Intervention: Drug: Placebo Placebo: Placebo IM for 24 weeks. | 0 | 35 | 0 | 35 | 27 | 35 |
| Headache | General disorders | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Itchiness at injection site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Irritability/anxiety | Psychiatric disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | Systematic Assessment |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
|
| Hunger | General disorders | Systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
|
| Decreased appetite | General disorders | Systematic Assessment |
|
| Sedation | General disorders | Systematic Assessment |
|
| Blurry vision | Eye disorders | Systematic Assessment |
|
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| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |
| Week 6 |
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| Week 12 |
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| Week 18 |
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| Week 24 |
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