Wednesday, December 15, 2010

US Government will conduct clinical trial to prove that informed consent can be considered as nocebo for SSRIs

I just came across with this clinical trial that should have started last October but, so sad, it didn't. Informed consent might trigger side efffects is the hypothesis they will study until 2013.
If you are not familiar with the concept of nocebo:

"A nocebo (Latin for "I will harm") is something that should be ineffective but which causes symptoms of ill health. A nocebo effect is an ill effect caused by the suggestion or belief that something is harmful. The term 'nocebo' became popular in the 1990s. Prior to that, both pleasant and harmful effects thought to be due to the power of suggestion were usually referred to as being due to the placebo effect.
Because of ethical concerns, nocebos are not commonly used in medical practice or research. Thus, it is not unexpected that the nocebo effect is not well-established in the scientific literature. However, there are some anecdotes and some studies that are commonly appealed to in the literature to support its validity." (here)
This is the clinical trial:
Detailed Description:
"In this study the investigators wish to inquire whether the nature of the explenation given to the patient as part of informed consent has an effect on the prevalence of side-effects. The study will take place in the out-patient clinic at the Shalvata Mental health Center. Three arms are included:
  1. 50 patients started on SSRI's will be updated about its common side effects
  2. 50 patients started on SSRI's will be updated about its common side effects and will receive an explenation on the nocebo effect
  3. 50 patients started on SSRI's will receive an explenation on the nocebo effect, but will not be updated about common side-effects. Nonetheless, they will be informed of severe side-effects.
Following the prescription of an SSRI the subjects will we enter the follow-up phase of the study. They will attend two follow-up meetings: 3 days after the initiation point and one month after the starting point. During each meeting they will be asked to fill the Antidepressant Side-Effect Checklist (ASEC)and the General Health Questionnaire (GHQ)."

If you were thinking about informed consent for drugs whose side effects are birth defects, suicidal ideation, violent behaviour, impossible withdrawal I believe you will have to wait.

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