A Phase 4 interventional study of Pravastatin and Placebo in Schizophrenia, Schizoaffective Disorders and Schizophreniform Disorders, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 68 Years. Per ClinicalTrials.gov, last updated 2014-04-28.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.
Browse Inflammation studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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Exclusion Criteria:
pravastatin 40mg, once a day, shortly after baseline for 12 consecutive weeks
Drug: Pravastatin
placebo, once a day, shortly after baseline for 12 consecutive weeks
Drug: Placebo
pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Also known as: pravastatin sodium, Pravachol
pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Change in LDL-cholesterol Between Baseline and Week 12
Time frame: Baseline, week 12
Change in C-Reactive Protein (CRP) From Baseline to Week 12
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, week 12
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.
Time frame: 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.
Time frame: Baseline, week 12
All participants were recruited from the Massachusetts General Hospital Schizophrenia Clinical and Research Program.
| Milestone | Pravastatin | Placebo |
|---|---|---|
| Started | 30 | 30 |
| Completed | 24 | 25 |
| Not completed | 6 | 5 |
| mg/dl | Pravastatin | Placebo |
|---|---|---|
| Change in LDL-cholesterol Between Baseline and Week 12 | -25.565 ± 32.261 | -2.913 ± 16.434 |
| mg/L | Pravastatin | Placebo |
|---|---|---|
| Change in C-Reactive Protein (CRP) From Baseline to Week 12 | 0.8063 ± 5.3515 | -0.5136 ± 7.2646 |
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.
| Scores on a scale | Pravastatin | Placebo |
|---|---|---|
| Change in MATRICS Neuropsychological Battery Composite Score From Baseline to Week 12 | 4.0417 ± 5.2789 | 4.125 ± 6.9739 |
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.
| Scores on a scale | Pravastatin | Placebo |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 12 | -9.416 ± 13.941 | -6.48 ± 12.003 |
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.
| Scores on a scale | Pravastatin | Placebo |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) Positive Score From Baseline to Week 12 | -2.9583 ± 3.014 | -2.44 ± 4.164 |
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.
| Scores on a scale | Pravastatin | Placebo |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) Negative Score From Baseline to Week 12 | -0.83 ± 5.411 | -0.28 ± 3.736 |
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.
| Scores on a scale | Pravastatin | Placebo |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) General Score From Baseline to Week 12 | -5.625 ± 8.155 | -3.76 ± 6.418 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pravastatin | — | 0/30 (0%) | 5/30 (16.7%) |
| Placebo | — | 0/30 (0%) | 1/30 (3.3%) |
| Event | Pravastatin | Placebo |
|---|---|---|
| Muscle sorenessMusculoskeletal and connective tissue disorders | 5/30 | 1/30 |
| Age, Categorical(Participants) | Pravastatin | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 30 | 30 | 60 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Pravastatin | Placebo | Total |
|---|---|---|---|
| Mean | 43.11 ± 11.06 | 45.08 ± 12.54 | 44.84 ± 11.35 |
| Sex: Female, Male(Participants) | Pravastatin | Placebo | Total |
|---|---|---|---|
| Female | 8 | 14 | 22 |
| Male | 22 | 16 | 38 |
| Region of Enrollment(participants) | Pravastatin | Placebo | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital