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Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective Disorders, Schizophreniform Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pravastatin
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, pravastatin, inflammation, cognition, antipsychotics, cholesterol

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female
  • Age 18-68 years
  • Diagnosis of schizophrenia, any subtype, schizoaffective disorder, any subtype or schizophreniform disorder
  • Well established compliance with outpatient medications including their antipsychotic medication

Exclusion Criteria:

  • Inability to provide informed consent
  • Current substance and alcohol abuse
  • Significant medical illness, including congestive heart failure, severe cardiovascular disease, renal disease (serum creatinine > 1.5), severe hepatic impairment or active liver disease, anemia (hemoglobin <11.0 gm/dL), history of severe head injury, and not treated muscle disease.
  • Psychiatrically unstable
  • Women of child bearing potential who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
  • Subjects treated with anti-inflammatory drugs (including daily aspirin and ibuprofen), thiazide diuretics; agents that induce weight loss, and St. John's Wort will be excluded from the study
  • Current history of untreated thyroid disease
  • Current treatment with insulin
  • Subjects being treated with drugs such as: colchicine, azole antifungals (fluconazole, ketoconazole, itraconazole); macrolide antibiotics (clarithromycin, erythromycin); HIV protease inhibitors (ritonavir, indinavir, saquinavir, nelfinavir) that inhibit the CYP 450 3A liver enzyme
  • Known hypersensitivity to pravastatin or any of its components

Sites / Locations

  • Freedom Trail Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

pravastatin

Placebo

Arm Description

pravastatin 40mg, once a day, shortly after baseline for 12 consecutive weeks

placebo, once a day, shortly after baseline for 12 consecutive weeks

Outcomes

Primary Outcome Measures

Change in LDL-cholesterol Between Baseline and Week 12
Change in C-Reactive Protein (CRP) From Baseline to 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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 5, 2010
Last Updated
March 26, 2014
Sponsor
Massachusetts General Hospital
Collaborators
Stanley Medical Research Institute, North Suffolk Mental Health Association
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1. Study Identification

Unique Protocol Identification Number
NCT01082588
Brief Title
Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia
Official Title
Phase 4 Study of the Effects of Pravastatin on Cholesterol Levels, Inflammation and Cognition in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Stanley Medical Research Institute, North Suffolk Mental Health Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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: Lower cholesterol Decrease inflammation Improve cognition in patients with schizophrenia
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorders, Schizophreniform Disorders
Keywords
schizophrenia, pravastatin, inflammation, cognition, antipsychotics, cholesterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pravastatin
Arm Type
Active Comparator
Arm Description
pravastatin 40mg, once a day, shortly after baseline for 12 consecutive weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo, once a day, shortly after baseline for 12 consecutive weeks
Intervention Type
Drug
Intervention Name(s)
Pravastatin
Other Intervention Name(s)
pravastatin sodium, Pravachol
Intervention Description
pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Primary Outcome Measure Information:
Title
Change in LDL-cholesterol Between Baseline and Week 12
Time Frame
Baseline, week 12
Title
Change in C-Reactive Protein (CRP) From Baseline to Week 12
Time Frame
Baseline, week 12
Title
Change in MATRICS Neuropsychological Battery Composite Score From Baseline to Week 12
Description
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
Title
Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 12
Description
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
Title
Change in Positive and Negative Syndrome Scale (PANSS) Positive Score From Baseline to Week 12
Description
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
Title
Change in Positive and Negative Syndrome Scale (PANSS) Negative Score From Baseline to Week 12
Description
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
Title
Change in Positive and Negative Syndrome Scale (PANSS) General Score From Baseline to Week 12
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female Age 18-68 years Diagnosis of schizophrenia, any subtype, schizoaffective disorder, any subtype or schizophreniform disorder Well established compliance with outpatient medications including their antipsychotic medication Exclusion Criteria: Inability to provide informed consent Current substance and alcohol abuse Significant medical illness, including congestive heart failure, severe cardiovascular disease, renal disease (serum creatinine > 1.5), severe hepatic impairment or active liver disease, anemia (hemoglobin <11.0 gm/dL), history of severe head injury, and not treated muscle disease. Psychiatrically unstable Women of child bearing potential who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study Subjects treated with anti-inflammatory drugs (including daily aspirin and ibuprofen), thiazide diuretics; agents that induce weight loss, and St. John's Wort will be excluded from the study Current history of untreated thyroid disease Current treatment with insulin Subjects being treated with drugs such as: colchicine, azole antifungals (fluconazole, ketoconazole, itraconazole); macrolide antibiotics (clarithromycin, erythromycin); HIV protease inhibitors (ritonavir, indinavir, saquinavir, nelfinavir) that inhibit the CYP 450 3A liver enzyme Known hypersensitivity to pravastatin or any of its components
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C Henderson, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Freedom Trail Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11268373
Citation
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.
Results Reference
background
PubMed Identifier
11950553
Citation
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.
Results Reference
background
PubMed Identifier
15840416
Citation
Sirota P, Meiman M, Herschko R, Bessler H. Effect of neuroleptic administration on serum levels of soluble IL-2 receptor-alpha and IL-1 receptor antagonist in schizophrenic patients. Psychiatry Res. 2005 Apr 15;134(2):151-9. doi: 10.1016/j.psychres.2004.04.012.
Results Reference
background
PubMed Identifier
7872033
Citation
Rapaport MH, Lohr JB. Serum-soluble interleukin-2 receptors in neuroleptic-naive schizophrenic subjects and in medicated schizophrenic subjects with and without tardive dyskinesia. Acta Psychiatr Scand. 1994 Nov;90(5):311-5. doi: 10.1111/j.1600-0447.1994.tb01599.x.
Results Reference
background
PubMed Identifier
18005941
Citation
Potvin S, Stip E, Sepehry AA, Gendron A, Bah R, Kouassi E. Inflammatory cytokine alterations in schizophrenia: a systematic quantitative review. Biol Psychiatry. 2008 Apr 15;63(8):801-8. doi: 10.1016/j.biopsych.2007.09.024. Epub 2007 Nov 19.
Results Reference
background
PubMed Identifier
9323355
Citation
Naudin J, Capo C, Giusano B, Mege JL, Azorin JM. A differential role for interleukin-6 and tumor necrosis factor-alpha in schizophrenia? Schizophr Res. 1997 Aug 29;26(2-3):227-33. doi: 10.1016/s0920-9964(97)00059-5.
Results Reference
background
PubMed Identifier
9247977
Citation
Monteleone P, Fabrazzo M, Tortorella A, Maj M. Plasma levels of interleukin-6 and tumor necrosis factor alpha in chronic schizophrenia: effects of clozapine treatment. Psychiatry Res. 1997 Jun 16;71(1):11-7. doi: 10.1016/s0165-1781(97)00036-x.
Results Reference
background
PubMed Identifier
11244489
Citation
Boin F, Zanardini R, Pioli R, Altamura CA, Maes M, Gennarelli M. Association between -G308A tumor necrosis factor alpha gene polymorphism and schizophrenia. Mol Psychiatry. 2001 Jan;6(1):79-82. doi: 10.1038/sj.mp.4000815.
Results Reference
background
PubMed Identifier
12888800
Citation
Meira-Lima IV, Pereira AC, Mota GF, Floriano M, Araujo F, Mansur AJ, Krieger JE, Vallada H. Analysis of a polymorphism in the promoter region of the tumor necrosis factor alpha gene in schizophrenia and bipolar disorder: further support for an association with schizophrenia. Mol Psychiatry. 2003 Aug;8(8):718-20. doi: 10.1038/sj.mp.4001309. No abstract available.
Results Reference
background
PubMed Identifier
8668926
Citation
Bouma G, Crusius JB, Oudkerk Pool M, Kolkman JJ, von Blomberg BM, Kostense PJ, Giphart MJ, Schreuder GM, Meuwissen SG, Pena AS. Secretion of tumour necrosis factor alpha and lymphotoxin alpha in relation to polymorphisms in the TNF genes and HLA-DR alleles. Relevance for inflammatory bowel disease. Scand J Immunol. 1996 Apr;43(4):456-63. doi: 10.1046/j.1365-3083.1996.d01-65.x.
Results Reference
background
PubMed Identifier
9096369
Citation
Wilson AG, Symons JA, McDowell TL, McDevitt HO, Duff GW. Effects of a polymorphism in the human tumor necrosis factor alpha promoter on transcriptional activation. Proc Natl Acad Sci U S A. 1997 Apr 1;94(7):3195-9. doi: 10.1073/pnas.94.7.3195.
Results Reference
background
PubMed Identifier
7653683
Citation
McAllister CG, van Kammen DP, Rehn TJ, Miller AL, Gurklis J, Kelley ME, Yao J, Peters JL. Increases in CSF levels of interleukin-2 in schizophrenia: effects of recurrence of psychosis and medication status. Am J Psychiatry. 1995 Sep;152(9):1291-7. doi: 10.1176/ajp.152.9.1291.
Results Reference
background
PubMed Identifier
15291683
Citation
Zhang XY, Zhou DF, Cao LY, Zhang PY, Wu GY, Shen YC. Changes in serum interleukin-2, -6, and -8 levels before and during treatment with risperidone and haloperidol: relationship to outcome in schizophrenia. J Clin Psychiatry. 2004 Jul;65(7):940-7. doi: 10.4088/jcp.v65n0710.
Results Reference
background
PubMed Identifier
17112596
Citation
Fan X, Pristach C, Liu EY, Freudenreich O, Henderson DC, Goff DC. Elevated serum levels of C-reactive protein are associated with more severe psychopathology in a subgroup of patients with schizophrenia. Psychiatry Res. 2007 Jan 15;149(1-3):267-71. doi: 10.1016/j.psychres.2006.07.011. Epub 2006 Nov 16.
Results Reference
background
PubMed Identifier
12042193
Citation
Muller N, Riedel M, Scheppach C, Brandstatter B, Sokullu S, Krampe K, Ulmschneider M, Engel RR, Moller HJ, Schwarz MJ. Beneficial antipsychotic effects of celecoxib add-on therapy compared to risperidone alone in schizophrenia. Am J Psychiatry. 2002 Jun;159(6):1029-34. doi: 10.1176/appi.ajp.159.6.1029.
Results Reference
background
PubMed Identifier
15953498
Citation
Rapaport MH, Delrahim KK, Bresee CJ, Maddux RE, Ahmadpour O, Dolnak D. Celecoxib augmentation of continuously ill patients with schizophrenia. Biol Psychiatry. 2005 Jun 15;57(12):1594-6. doi: 10.1016/j.biopsych.2005.02.024.
Results Reference
background
PubMed Identifier
16948290
Citation
Dziedzic T. Systemic inflammatory markers and risk of dementia. Am J Alzheimers Dis Other Demen. 2006 Aug-Sep;21(4):258-62. doi: 10.1177/1533317506289260.
Results Reference
background
PubMed Identifier
10674995
Citation
Licastro F, Pedrini S, Caputo L, Annoni G, Davis LJ, Ferri C, Casadei V, Grimaldi LM. Increased plasma levels of interleukin-1, interleukin-6 and alpha-1-antichymotrypsin in patients with Alzheimer's disease: peripheral inflammation or signals from the brain? J Neuroimmunol. 2000 Feb 1;103(1):97-102. doi: 10.1016/s0165-5728(99)00226-x.
Results Reference
background
PubMed Identifier
10462168
Citation
Bruunsgaard H, Andersen-Ranberg K, Jeune B, Pedersen AN, Skinhoj P, Pedersen BK. A high plasma concentration of TNF-alpha is associated with dementia in centenarians. J Gerontol A Biol Sci Med Sci. 1999 Jul;54(7):M357-64. doi: 10.1093/gerona/54.7.m357.
Results Reference
background
PubMed Identifier
12847160
Citation
Yaffe K, Lindquist K, Penninx BW, Simonsick EM, Pahor M, Kritchevsky S, Launer L, Kuller L, Rubin S, Harris T. Inflammatory markers and cognition in well-functioning African-American and white elders. Neurology. 2003 Jul 8;61(1):76-80. doi: 10.1212/01.wnl.0000073620.42047.d7.
Results Reference
background
PubMed Identifier
17536046
Citation
Tan ZS, Beiser AS, Vasan RS, Roubenoff R, Dinarello CA, Harris TB, Benjamin EJ, Au R, Kiel DP, Wolf PA, Seshadri S. Inflammatory markers and the risk of Alzheimer disease: the Framingham Study. Neurology. 2007 May 29;68(22):1902-8. doi: 10.1212/01.wnl.0000263217.36439.da.
Results Reference
background
PubMed Identifier
12869452
Citation
Etminan M, Gill S, Samii A. Effect of non-steroidal anti-inflammatory drugs on risk of Alzheimer's disease: systematic review and meta-analysis of observational studies. BMJ. 2003 Jul 19;327(7407):128. doi: 10.1136/bmj.327.7407.128.
Results Reference
background
PubMed Identifier
17490859
Citation
Dickerson F, Stallings C, Origoni A, Boronow J, Yolken R. C-reactive protein is associated with the severity of cognitive impairment but not of psychiatric symptoms in individuals with schizophrenia. Schizophr Res. 2007 Jul;93(1-3):261-5. doi: 10.1016/j.schres.2007.03.022. Epub 2007 May 8.
Results Reference
background
PubMed Identifier
19640511
Citation
Meyer JM, McEvoy JP, Davis VG, Goff DC, Nasrallah HA, Davis SM, Hsiao JK, Swartz MS, Stroup TS, Lieberman JA. Inflammatory markers in schizophrenia: comparing antipsychotic effects in phase 1 of the clinical antipsychotic trials of intervention effectiveness study. Biol Psychiatry. 2009 Dec 1;66(11):1013-22. doi: 10.1016/j.biopsych.2009.06.005. Epub 2009 Jul 29.
Results Reference
background
PubMed Identifier
10650444
Citation
Fenton WS, Hibbeln J, Knable M. Essential fatty acids, lipid membrane abnormalities, and the diagnosis and treatment of schizophrenia. Biol Psychiatry. 2000 Jan 1;47(1):8-21. doi: 10.1016/s0006-3223(99)00092-x.
Results Reference
background
PubMed Identifier
12490958
Citation
Tracey KJ. The inflammatory reflex. Nature. 2002 Dec 19-26;420(6917):853-9. doi: 10.1038/nature01321.
Results Reference
background
PubMed Identifier
10386984
Citation
Laflamme N, Rivest S. Effects of systemic immunogenic insults and circulating proinflammatory cytokines on the transcription of the inhibitory factor kappaB alpha within specific cellular populations of the rat brain. J Neurochem. 1999 Jul;73(1):309-21. doi: 10.1046/j.1471-4159.1999.0730309.x.
Results Reference
background
PubMed Identifier
11260702
Citation
Ek M, Engblom D, Saha S, Blomqvist A, Jakobsson PJ, Ericsson-Dahlstrand A. Inflammatory response: pathway across the blood-brain barrier. Nature. 2001 Mar 22;410(6827):430-1. doi: 10.1038/35068632. No abstract available.
Results Reference
background
PubMed Identifier
17220915
Citation
Perry VH, Cunningham C, Holmes C. Systemic infections and inflammation affect chronic neurodegeneration. Nat Rev Immunol. 2007 Feb;7(2):161-7. doi: 10.1038/nri2015. Epub 2007 Jan 15.
Results Reference
background
PubMed Identifier
15991254
Citation
Sjoholm A, Nystrom T. Inflammation and the etiology of type 2 diabetes. Diabetes Metab Res Rev. 2006 Jan-Feb;22(1):4-10. doi: 10.1002/dmrr.568.
Results Reference
background
PubMed Identifier
7678183
Citation
Hotamisligil GS, Shargill NS, Spiegelman BM. Adipose expression of tumor necrosis factor-alpha: direct role in obesity-linked insulin resistance. Science. 1993 Jan 1;259(5091):87-91. doi: 10.1126/science.7678183.
Results Reference
background
PubMed Identifier
15211090
Citation
Dandona P, Aljada A, Chaudhuri A, Mohanty P. Endothelial dysfunction, inflammation and diabetes. Rev Endocr Metab Disord. 2004 Aug;5(3):189-97. doi: 10.1023/B:REMD.0000032407.88070.0a. No abstract available.
Results Reference
background
PubMed Identifier
8571133
Citation
Hotamisligil GS, Peraldi P, Budavari A, Ellis R, White MF, Spiegelman BM. IRS-1-mediated inhibition of insulin receptor tyrosine kinase activity in TNF-alpha- and obesity-induced insulin resistance. Science. 1996 Feb 2;271(5249):665-8. doi: 10.1126/science.271.5249.665.
Results Reference
background
PubMed Identifier
16137860
Citation
McEvoy JP, Meyer JM, Goff DC, Nasrallah HA, Davis SM, Sullivan L, Meltzer HY, Hsiao J, Scott Stroup T, Lieberman JA. Prevalence of the metabolic syndrome in patients with schizophrenia: baseline results from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial and comparison with national estimates from NHANES III. Schizophr Res. 2005 Dec 1;80(1):19-32. doi: 10.1016/j.schres.2005.07.014. Epub 2005 Aug 30.
Results Reference
background
PubMed Identifier
15136311
Citation
Ford DE, Erlinger TP. Depression and C-reactive protein in US adults: data from the Third National Health and Nutrition Examination Survey. Arch Intern Med. 2004 May 10;164(9):1010-4. doi: 10.1001/archinte.164.9.1010.
Results Reference
background
PubMed Identifier
12460094
Citation
Lakka HM, Laaksonen DE, Lakka TA, Niskanen LK, Kumpusalo E, Tuomilehto J, Salonen JT. The metabolic syndrome and total and cardiovascular disease mortality in middle-aged men. JAMA. 2002 Dec 4;288(21):2709-16. doi: 10.1001/jama.288.21.2709.
Results Reference
background
PubMed Identifier
11926934
Citation
Newcomer JW, Haupt DW, Fucetola R, Melson AK, Schweiger JA, Cooper BP, Selke G. Abnormalities in glucose regulation during antipsychotic treatment of schizophrenia. Arch Gen Psychiatry. 2002 Apr;59(4):337-45. doi: 10.1001/archpsyc.59.4.337.
Results Reference
background
PubMed Identifier
15630069
Citation
Henderson DC, Cagliero E, Copeland PM, Borba CP, Evins AE, Hayden D, Weber MT, Anderson EJ, Allison DB, Daley TB, Schoenfeld D, Goff DC. Glucose metabolism in patients with schizophrenia treated with atypical antipsychotic agents: a frequently sampled intravenous glucose tolerance test and minimal model analysis. Arch Gen Psychiatry. 2005 Jan;62(1):19-28. doi: 10.1001/archpsyc.62.1.19. Erratum In: JAMA Psychiatry. 2017 Jul 1;74(7):764. JAMA Psychiatry. 2018 Aug 1;75(8):866.
Results Reference
background
PubMed Identifier
9753305
Citation
Bonora E, Kiechl S, Willeit J, Oberhollenzer F, Egger G, Targher G, Alberiche M, Bonadonna RC, Muggeo M. Prevalence of insulin resistance in metabolic disorders: the Bruneck Study. Diabetes. 1998 Oct;47(10):1643-9. doi: 10.2337/diabetes.47.10.1643.
Results Reference
background
PubMed Identifier
16046308
Citation
Kitabchi AE, Temprosa M, Knowler WC, Kahn SE, Fowler SE, Haffner SM, Andres R, Saudek C, Edelstein SL, Arakaki R, Murphy MB, Shamoon H; Diabetes Prevention Program Research Group. Role of insulin secretion and sensitivity in the evolution of type 2 diabetes in the diabetes prevention program: effects of lifestyle intervention and metformin. Diabetes. 2005 Aug;54(8):2404-14. doi: 10.2337/diabetes.54.8.2404.
Results Reference
background
PubMed Identifier
8247074
Citation
Lillioja S, Mott DM, Spraul M, Ferraro R, Foley JE, Ravussin E, Knowler WC, Bennett PH, Bogardus C. Insulin resistance and insulin secretory dysfunction as precursors of non-insulin-dependent diabetes mellitus. Prospective studies of Pima Indians. N Engl J Med. 1993 Dec 30;329(27):1988-92. doi: 10.1056/NEJM199312303292703.
Results Reference
background
PubMed Identifier
16823479
Citation
Semenkovich CF. Insulin resistance and atherosclerosis. J Clin Invest. 2006 Jul;116(7):1813-22. doi: 10.1172/JCI29024.
Results Reference
background
PubMed Identifier
11194248
Citation
Weyer C, Tataranni PA, Bogardus C, Pratley RE. Insulin resistance and insulin secretory dysfunction are independent predictors of worsening of glucose tolerance during each stage of type 2 diabetes development. Diabetes Care. 2001 Jan;24(1):89-94. doi: 10.2337/diacare.24.1.89.
Results Reference
background
PubMed Identifier
15864338
Citation
Wellen KE, Hotamisligil GS. Inflammation, stress, and diabetes. J Clin Invest. 2005 May;115(5):1111-9. doi: 10.1172/JCI25102.
Results Reference
background
PubMed Identifier
16265333
Citation
Nissen SE. Does intensive statin therapy lower mortality and cardiovascular event risk in patients with acute coronary syndrome? Nat Clin Pract Cardiovasc Med. 2005 Jan;2(1):10-1. doi: 10.1038/ncpcardio0066. No abstract available.
Results Reference
background
PubMed Identifier
15635110
Citation
Nissen SE, Tuzcu EM, Schoenhagen P, Crowe T, Sasiela WJ, Tsai J, Orazem J, Magorien RD, O'Shaughnessy C, Ganz P; Reversal of Atherosclerosis with Aggressive Lipid Lowering (REVERSAL) Investigators. Statin therapy, LDL cholesterol, C-reactive protein, and coronary artery disease. N Engl J Med. 2005 Jan 6;352(1):29-38. doi: 10.1056/NEJMoa042000.
Results Reference
background
PubMed Identifier
15893181
Citation
Ridker PM, Morrow DA, Rose LM, Rifai N, Cannon CP, Braunwald E. Relative efficacy of atorvastatin 80 mg and pravastatin 40 mg in achieving the dual goals of low-density lipoprotein cholesterol <70 mg/dl and C-reactive protein <2 mg/l: an analysis of the PROVE-IT TIMI-22 trial. J Am Coll Cardiol. 2005 May 17;45(10):1644-8. doi: 10.1016/j.jacc.2005.02.080. Epub 2005 Apr 25.
Results Reference
background
PubMed Identifier
9935036
Citation
Kaesemeyer WH, Caldwell RB, Huang J, Caldwell RW. Pravastatin sodium activates endothelial nitric oxide synthase independent of its cholesterol-lowering actions. J Am Coll Cardiol. 1999 Jan;33(1):234-41. doi: 10.1016/s0735-1097(98)00514-2.
Results Reference
background
PubMed Identifier
15310527
Citation
Harris JI, Hibbeln JR, Mackey RH, Muldoon MF. Statin treatment alters serum n-3 and n-6 fatty acids in hypercholesterolemic patients. Prostaglandins Leukot Essent Fatty Acids. 2004 Oct;71(4):263-9. doi: 10.1016/j.plefa.2004.06.001.
Results Reference
background
PubMed Identifier
15829284
Citation
Agrawal A. CRP after 2004. Mol Immunol. 2005 May;42(8):927-30. doi: 10.1016/j.molimm.2004.09.028. Epub 2004 Dec 7.
Results Reference
background
PubMed Identifier
15337754
Citation
Black S, Kushner I, Samols D. C-reactive Protein. J Biol Chem. 2004 Nov 19;279(47):48487-90. doi: 10.1074/jbc.R400025200. Epub 2004 Aug 26.
Results Reference
background
PubMed Identifier
15635109
Citation
Ridker PM, Cannon CP, Morrow D, Rifai N, Rose LM, McCabe CH, Pfeffer MA, Braunwald E; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) Investigators. C-reactive protein levels and outcomes after statin therapy. N Engl J Med. 2005 Jan 6;352(1):20-8. doi: 10.1056/NEJMoa042378.
Results Reference
background
PubMed Identifier
16960448
Citation
Vuletic S, Riekse RG, Marcovina SM, Peskind ER, Hazzard WR, Albers JJ. Statins of different brain penetrability differentially affect CSF PLTP activity. Dement Geriatr Cogn Disord. 2006;22(5-6):392-8. doi: 10.1159/000095679. Epub 2006 Sep 7.
Results Reference
background
PubMed Identifier
9705054
Citation
Ventura J, Liberman RP, Green MF, Shaner A, Mintz J. Training and quality assurance with the Structured Clinical Interview for DSM-IV (SCID-I/P). Psychiatry Res. 1998 Jun 15;79(2):163-73. doi: 10.1016/s0165-1781(98)00038-9.
Results Reference
background
PubMed Identifier
2619982
Citation
Kay SR, Opler LA, Lindenmayer JP. The Positive and Negative Syndrome Scale (PANSS): rationale and standardisation. Br J Psychiatry Suppl. 1989 Nov;(7):59-67. No abstract available.
Results Reference
background
PubMed Identifier
6973337
Citation
Rey JM, Hunt GE, Johnson GF. Assessment of tardive dyskinesia in psychiatric outpatients using a standardized rating scale. Aust N Z J Psychiatry. 1981 Mar;15(1):33-7. doi: 10.3109/00048678109159407.
Results Reference
background
PubMed Identifier
14399272
Citation
HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
Results Reference
background
PubMed Identifier
6474101
Citation
Heinrichs DW, Hanlon TE, Carpenter WT Jr. The Quality of Life Scale: an instrument for rating the schizophrenic deficit syndrome. Schizophr Bull. 1984;10(3):388-98. doi: 10.1093/schbul/10.3.388.
Results Reference
background
PubMed Identifier
938196
Citation
Endicott J, Spitzer RL, Fleiss JL, Cohen J. The global assessment scale. A procedure for measuring overall severity of psychiatric disturbance. Arch Gen Psychiatry. 1976 Jun;33(6):766-71. doi: 10.1001/archpsyc.1976.01770060086012.
Results Reference
background
PubMed Identifier
18172019
Citation
Nuechterlein KH, Green MF, Kern RS, Baade LE, Barch DM, Cohen JD, Essock S, Fenton WS, Frese FJ 3rd, Gold JM, Goldberg T, Heaton RK, Keefe RS, Kraemer H, Mesholam-Gately R, Seidman LJ, Stover E, Weinberger DR, Young AS, Zalcman S, Marder SR. The MATRICS Consensus Cognitive Battery, part 1: test selection, reliability, and validity. Am J Psychiatry. 2008 Feb;165(2):203-13. doi: 10.1176/appi.ajp.2007.07010042. Epub 2008 Jan 2.
Results Reference
background
PubMed Identifier
18172018
Citation
Kern RS, Nuechterlein KH, Green MF, Baade LE, Fenton WS, Gold JM, Keefe RS, Mesholam-Gately R, Mintz J, Seidman LJ, Stover E, Marder SR. The MATRICS Consensus Cognitive Battery, part 2: co-norming and standardization. Am J Psychiatry. 2008 Feb;165(2):214-20. doi: 10.1176/appi.ajp.2007.07010043. Epub 2008 Jan 2.
Results Reference
background
PubMed Identifier
11354591
Citation
Patterson TL, Goldman S, McKibbin CL, Hughs T, Jeste DV. UCSD Performance-Based Skills Assessment: development of a new measure of everyday functioning for severely mentally ill adults. Schizophr Bull. 2001;27(2):235-45. doi: 10.1093/oxfordjournals.schbul.a006870.
Results Reference
background
PubMed Identifier
3171020
Citation
Schakel SF, Sievert YA, Buzzard IM. Sources of data for developing and maintaining a nutrient database. J Am Diet Assoc. 1988 Oct;88(10):1268-71.
Results Reference
background
PubMed Identifier
3608193
Citation
McNamara JR, Schaefer EJ. Automated enzymatic standardized lipid analyses for plasma and lipoprotein fractions. Clin Chim Acta. 1987 Jun 30;166(1):1-8. doi: 10.1016/0009-8981(87)90188-4.
Results Reference
background
PubMed Identifier
7074948
Citation
Warnick GR, Benderson J, Albers JJ. Dextran sulfate-Mg2+ precipitation procedure for quantitation of high-density-lipoprotein cholesterol. Clin Chem. 1982 Jun;28(6):1379-88. No abstract available.
Results Reference
background
PubMed Identifier
4337382
Citation
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.
Results Reference
background
PubMed Identifier
11934219
Citation
Otvos JD. Measurement of lipoprotein subclass profiles by nuclear magnetic resonance spectroscopy. Clin Lab. 2002;48(3-4):171-80. No abstract available.
Results Reference
background
PubMed Identifier
3088916
Citation
Levine S. The management of resistant depression. Acta Psychiatr Belg. 1986 Mar-Apr;86(2):141-51.
Results Reference
background

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Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia

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