SchizophreniaPhase 4NCT01082588

Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia

A Phase 4 study testing Pravastatin in people with Schizophrenia and Schizoaffective Disorders, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 68 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorders, Schizophreniform Disorders
What is being tested?: Pravastatin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Sep 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 68 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Freedom Trail Clinic
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Phase 4 Study of the Effects of Pravastatin on Cholesterol Levels, Inflammation and Cognition in Schizophrenia

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

Read the 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.

Conditions: Schizophrenia, Schizoaffective Disorders, Schizophreniform Disorders
Being tested: Pravastatin, Placebo
Keywords: schizophrenia, pravastatin, inflammation, cognition, antipsychotics, cholesterol
Medical subject headings: Schizophrenia, Psychotic Disorders, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PravastatinDrug
Also called pravastatin sodium, Pravachol
pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
PlaceboDrug
pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks

Study groups in NCT01082588
Study group	Role	What they receive
pravastatin	Active comparator	pravastatin 40mg, once a day, shortly after baseline for 12 consecutive weeks Receives: Drug: Pravastatin
Placebo	Placebo comparator	placebo, once a day, shortly after baseline for 12 consecutive weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Sep 2012

First posted8 Mar 2010 (estimated)
Study startJun 2010
Primary completionSep 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (68)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01082588
Sponsor's protocol ID: 2009-P-002524
Other IDs: 09T-1296
Status last verified: Mar 2014
First submitted: 5 Mar 2010
Last updated: 28 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 11268373
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.
PubMed 11950553
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.
PubMed 15840416
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.
PubMed 7872033
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.
PubMed 18005941
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.
PubMed 9323355
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.
PubMed 9247977
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.
PubMed 11244489
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.
PubMed 12888800
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.
PubMed 8668926
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.
PubMed 9096369
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.
PubMed 7653683
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.
PubMed 15291683
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.
PubMed 17112596
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.
PubMed 12042193

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 4 Study of the Effects of Pravastatin on Cholesterol Levels, Inflammation and Cognition in Schizophrenia
ClinicalTrials.gov ID: NCT01082588
Acronym / sponsor ID: 2009-P-002524
Conditions: Schizophrenia, Schizoaffective Disorders, Schizophreniform Disorders
Keywords: schizophrenia, pravastatin, inflammation, cognition, antipsychotics, cholesterol
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Stanley Medical Research Institute, North Suffolk Mental Health Association
Study start: Jun 2010
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 8 Mar 2010 (estimated)
Results: Posted 28 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Lower cholesterol
Decrease inflammation
Improve cognition in patients with schizophrenia

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
pravastatin	Active comparator	Drug: Pravastatinpravastatin 40mg, once a day, shortly after baseline for 12 consecutive weeks
Placebo	Placebo comparator	Drug: Placeboplacebo, once a day, shortly after baseline for 12 consecutive weeks

Who may qualify

Ages: 18 to 68 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PravastatinAlso: pravastatin sodium, Pravacholpravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks	Drug	pravastatin
Placebopravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks	Drug	Placebo

Primary outcome

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
Time frame: Baseline, 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
Time frame: Baseline, 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
Time frame: Baseline, 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
Time frame: Baseline, 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
Time frame: Baseline, 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.

Results and safety

Results posted to the registry on 28 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pravastatin	30	24
Placebo	30	25

Primary outcome: Change in LDL-cholesterol Between Baseline and Week 12

Time frame: Baseline, week 12. Mean (Standard Deviation). Unit: mg/dl

Measure	Pravastatin n = 23	Placebo n = 23
Value	-25.565 (32.261)	-2.913 (16.434)

Population analysed: 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.

Primary outcome: Change in C-Reactive Protein (CRP) From Baseline to Week 12

Time frame: Baseline, week 12. Mean (Standard Deviation). Unit: mg/L

Measure	Pravastatin n = 24	Placebo n = 25
Value	0.8063 (5.3515)	-0.5136 (7.2646)

Primary outcome: Change in MATRICS Neuropsychological Battery Composite Score From Baseline to Week 12

Time frame: Baseline, week 12. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Pravastatin n = 24	Placebo n = 24
Value	4.0417 (5.2789)	4.125 (6.9739)

Population analysed: 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.

Primary outcome: Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 12

Time frame: Baseline, week 12. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Pravastatin n = 24	Placebo n = 25
Value	-9.416 (13.941)	-6.48 (12.003)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pravastatin	0 of 30 (0%)	5 of 30 (16.7%)	Not reported
Placebo	0 of 30 (0%)	1 of 30 (3.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11268373Muller 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.
Background: PubMed 11950553Maes 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.
Background: PubMed 15840416Sirota 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.
Background: PubMed 7872033Rapaport 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.
Background: PubMed 18005941Potvin 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.
Background: PubMed 9323355Naudin 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.
Background: PubMed 9247977Monteleone 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.
Background: PubMed 11244489Boin 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.
Background: PubMed 12888800Meira-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.
Background: PubMed 8668926Bouma 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.
Background: PubMed 9096369Wilson 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.
Background: PubMed 7653683McAllister 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David C Henderson, M.D. principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pravastatin in people with Schizophrenia and Schizoaffective Disorders, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in LDL-cholesterol Between Baseline and Week 12 (time frame: Baseline, week 12). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01082588, which also lists 68 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2014.