Trial Outcomes & Findings for Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia (NCT NCT01082588)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

Baseline, week 12

Results posted on

2014-04-28

Participant Flow

All participants were recruited from the Massachusetts General Hospital Schizophrenia Clinical and Research Program.

Participant milestones

Participant milestones
Measure	Pravastatin 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
Overall Study STARTED	30	30
Overall Study COMPLETED	24	25
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pravastatin n=30 Participants pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks	Placebo n=30 Participants pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	43.11 years STANDARD_DEVIATION 11.06 • n=5 Participants	45.08 years STANDARD_DEVIATION 12.54 • n=7 Participants	44.84 years STANDARD_DEVIATION 11.35 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	16 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, week 12

Population: 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.

Outcome measures

Outcome measures
Measure	Pravastatin n=23 Participants pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks	Placebo n=23 Participants pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Change in LDL-cholesterol Between Baseline and Week 12	-25.565 mg/dl Standard Deviation 32.261	-2.913 mg/dl Standard Deviation 16.434

PRIMARY outcome

Timeframe: Baseline, week 12

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks	Placebo n=25 Participants pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Change in C-Reactive Protein (CRP) From Baseline to Week 12	0.8063 mg/L Standard Deviation 5.3515	-0.5136 mg/L Standard Deviation 7.2646

PRIMARY outcome

Timeframe: Baseline, week 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks	Placebo n=24 Participants pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Change in MATRICS Neuropsychological Battery Composite Score From Baseline to Week 12	4.0417 Scores on a scale Standard Deviation 5.2789	4.125 Scores on a scale Standard Deviation 6.9739

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks	Placebo n=25 Participants pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 12	-9.416 Scores on a scale Standard Deviation 13.941	-6.48 Scores on a scale Standard Deviation 12.003

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks	Placebo n=25 Participants pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Change in Positive and Negative Syndrome Scale (PANSS) Positive Score From Baseline to Week 12	-2.9583 Scores on a scale Standard Deviation 3.014	-2.44 Scores on a scale Standard Deviation 4.164

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks	Placebo n=25 Participants pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Change in Positive and Negative Syndrome Scale (PANSS) Negative Score From Baseline to Week 12	-0.83 Scores on a scale Standard Deviation 5.411	-0.28 Scores on a scale Standard Deviation 3.736

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pravastatin n=24 Participants pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks	Placebo n=25 Participants pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Change in Positive and Negative Syndrome Scale (PANSS) General Score From Baseline to Week 12	-5.625 Scores on a scale Standard Deviation 8.155	-3.76 Scores on a scale Standard Deviation 6.418

Adverse Events

Pravastatin

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pravastatin n=30 participants at risk 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	Placebo n=30 participants at risk 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
Musculoskeletal and connective tissue disorders Muscle soreness	16.7% 5/30 • Number of events 5	3.3% 1/30 • Number of events 1

Additional Information

Dr. David Henderson

Massachusetts General Hospital

Phone: 617-912-7800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place