| ID | Type | Description | Link |
|---|---|---|---|
| 09T-1296 | Other Grant/Funding Number | Stanley Medical Research Institute |
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| Name | Class |
|---|---|
| Stanley Medical Research Institute | OTHER |
| North Suffolk Mental Health Association | OTHER |
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This study involves people with schizophrenia or schizoaffective disorder, who are currently taking antipsychotic medications. Some antipsychotic medications may cause an increase in cholesterol levels, which may lead to inflammation in the body. Inflammation poses a risk in developing heart disease, diabetes and problems with brain function. The purpose of this study is to see if pravastatin can:
This study is a 12-week randomized, double-blind, placebo-controlled pilot study of pravastatin 40mg a day, administered for 12 consecutive weeks to subjects with schizophrenia to examine pravastatin's effects on lowering cholesterol levels and inflammatory markers, and improving cognition. The study will be conducted at the Freedom Trail Clinic and will use the Massachusetts General Hospital Clinical Research Center. The innovative approach of using pravastatin to not only decrease cholesterol levels, but to decrease inflammation and improve cognition in patients with schizophrenia is promising and may lead to a different approach to treatment in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pravastatin | Active Comparator | pravastatin 40mg, once a day, shortly after baseline for 12 consecutive weeks |
|
| Placebo | Placebo Comparator | placebo, once a day, shortly after baseline for 12 consecutive weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pravastatin | Drug | pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL-cholesterol Between Baseline and Week 12 | Baseline, week 12 | |
| Change in C-Reactive Protein (CRP) From Baseline to Week 12 | Baseline, week 12 | |
| Change in MATRICS Neuropsychological Battery Composite Score From Baseline to Week 12 | The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery measures cognitive functioning within 7 domains: speed of processing, attention/vigilance, working memory (non verbal and verbal), verbal learning, visual learning, reasoning and problem solving and social cognition. The composite score is calculated by the MATRICS computer program, which equally weights each of the 7 domain scores. The range of composite scores is 20-80. Higher scores indicate higher levels or cognitive functioning, while lower scores indicate lower levels of cognitive functioning. | Baseline, week 12 |
| Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 12 | The Positive and Negative Syndrome Scale (PANSS) is a scale used to rate severity of schizophrenia. All items are summed to calculate the total score. The scale range is 30-210. Better outcomes have lower numbers and worse outcomes have higher numbers. | Baseline, week 12 |
| Change in Positive and Negative Syndrome Scale (PANSS) Positive Score From Baseline to Week 12 | This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers. | Baseline, week 12 |
| Change in Positive and Negative Syndrome Scale (PANSS) Negative Score From Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David C Henderson, M.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Freedom Trail Clinic | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11268373 | Background | Muller N, Riedel M, Gruber R, Ackenheil M, Schwarz MJ. The immune system and schizophrenia. An integrative view. Ann N Y Acad Sci. 2000;917:456-67. doi: 10.1111/j.1749-6632.2000.tb05410.x. | |
| 11950553 | Background | Maes M, Bocchio Chiavetto L, Bignotti S, Battisa Tura GJ, Pioli R, Boin F, Kenis G, Bosmans E, de Jongh R, Altamura CA. Increased serum interleukin-8 and interleukin-10 in schizophrenic patients resistant to treatment with neuroleptics and the stimulatory effects of clozapine on serum leukemia inhibitory factor receptor. Schizophr Res. 2002 Apr 1;54(3):281-91. doi: 10.1016/s0920-9964(00)00094-3. |
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All participants were recruited from the Massachusetts General Hospital Schizophrenia Clinical and Research Program.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pravastatin | pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks |
| FG001 | Placebo | pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pravastatin | pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks |
| BG001 | Placebo | pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks |
| 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 | Change in LDL-cholesterol Between Baseline and Week 12 | One participant from the pravastatin group and two from the placebo group had triglyceride levels above 400. Per Massachusetts General Hospital Laboratories policy, LDL is not run as a part of the complete metabolic panel (CMP) when triglycerides are above 400, and therefore could not be included in the final analysis. | Posted | Mean | Standard Deviation | mg/dl | Baseline, week 12 |
|
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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 | Pravastatin | pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks Pravastatin: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Henderson | Massachusetts General Hospital | 617-912-7800 | dchenderson@partners.org |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks |
|
This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers. |
| Baseline, week 12 |
| Change in Positive and Negative Syndrome Scale (PANSS) General Score From Baseline to Week 12 | This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 15-105. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers. | Baseline, week 12 |
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| 4337382 | Background | Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available. |
| 11934219 | Background | Otvos JD. Measurement of lipoprotein subclass profiles by nuclear magnetic resonance spectroscopy. Clin Lab. 2002;48(3-4):171-80. No abstract available. |
| 3088916 | Background | Levine S. The management of resistant depression. Acta Psychiatr Belg. 1986 Mar-Apr;86(2):141-51. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Change in C-Reactive Protein (CRP) From Baseline to Week 12 | Posted | Mean | Standard Deviation | mg/L | Baseline, week 12 |
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| Primary | Change in MATRICS Neuropsychological Battery Composite Score From Baseline to Week 12 | The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery measures cognitive functioning within 7 domains: speed of processing, attention/vigilance, working memory (non verbal and verbal), verbal learning, visual learning, reasoning and problem solving and social cognition. The composite score is calculated by the MATRICS computer program, which equally weights each of the 7 domain scores. The range of composite scores is 20-80. Higher scores indicate higher levels or cognitive functioning, while lower scores indicate lower levels of cognitive functioning. | One participant from the placebo group refused to complete the MATRICS assessment at week 12; therefore, we could only analyze 24 placebo participants for the final analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, week 12 |
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| Primary | Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 12 | The Positive and Negative Syndrome Scale (PANSS) is a scale used to rate severity of schizophrenia. All items are summed to calculate the total score. The scale range is 30-210. Better outcomes have lower numbers and worse outcomes have higher numbers. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, week 12 |
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| Primary | Change in Positive and Negative Syndrome Scale (PANSS) Positive Score From Baseline to Week 12 | This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, week 12 |
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| Primary | Change in Positive and Negative Syndrome Scale (PANSS) Negative Score From Baseline to Week 12 | This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, week 12 |
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| Primary | Change in Positive and Negative Syndrome Scale (PANSS) General Score From Baseline to Week 12 | This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 15-105. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, week 12 |
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| 0 |
| 30 |
| 5 |
| 30 |
| EG001 | Placebo | pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks Placebo: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks | 0 | 30 | 1 | 30 |
Not provided
Not provided
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |