Self-Assessment Method for Statin Side-effects Or Nocebo (SAMSON)
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|ClinicalTrials.gov Identifier: NCT02668016|
Recruitment Status : Active, not recruiting
First Posted : January 29, 2016
Last Update Posted : August 10, 2020
Front-line clinicians cannot currently test for an individual participant whether symptoms experienced are the pharmacological result of a statin or due to other phenomena. In this trial, participants who have previously ceased statins due to side effects will be offered the opportunity to undergo twelve randomly ordered 1-month periods. There will be four periods of no medication, four periods of placebo and four periods of statin. The placebo and the statin pills will be identical in appearance. Participants will record on a daily basis side-effects experienced. At the end of the study, the one-month sessions are sorted into the order shown above. The participant can then observe directly how much of the increase in symptoms seen with statin is also seen with placebo.
- Hypothesis 1: that >30% of participants enrolling for the study will complete it.
- Hypothesis 2: Overall >50% of symptom burden is nocebo rather than pharmacological
- The investigators will define the Nocebo proportion of side effects.
- Hypothesis 3: that the majority of participants, at 6 months after completion, will either be taking statins or have declined statins for reasons other than perceived side effects.
|Condition or disease||Intervention/treatment||Phase|
|Adverse Effects Cardiovascular Diseases Hyperlipidemias||Drug: Atorvastatin Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Self-Assessment Method for Statin Side-effects Or Nocebo|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||March 15, 2020|
|Estimated Study Completion Date :||September 1, 2020|
Experimental: Atorvastatin 20mg Daily
Atorvastatin 20mg daily for 1 month
Atorvastatin 20mg tablets taken orally once daily for one month.
Placebo Comparator: Placebo
Placebo daily for 1 month
Placebo tablets taken orally once daily for one month
No Intervention: No Treatment
No Atorvastatin or placebo for 1 month
- Individual Nocebo Proportion [ Time Frame: 12 months ]The individual nocebo proportion will be calculated at the end of the 12-months of the trial for each participant. The mean symptom scores for the four months on each arm will be calculated: placebo (mN) , Atorvastatin 20mg OD (mA) and no treatment (mZ). The Nocebo Proportion is (mN-mZ)/(mA-mZ). Let the averages of these standard deviations be respectively sA, sN, sZ. As long as mZ is small compared to mA and mN, and sA is not large in relation to mA, a reasonable approximation to the fractional standard error of the nocebo proportion will be calculated: (mN-mZ)/(mA-mZ) is (sA/mA + sN/mN) /112.
- Currently prescribed statins [ Time Frame: 6-months after end of trial ]Following the end of the trial, is the trial participant taking statins or not.
- Attribution of adverse symptoms [ Time Frame: 6-months after end of trial ]Following the end of the trial, whether individual trial participants currently believe that most of the side-effects previously attributed to the statin, were indeed a pharmacological effect of the statin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668016
|Imperial College London|
|London, Greater London, United Kingdom, W12 0HS|
|Principal Investigator:||Darrel Francis, MB MD||Imperial College London|