June 04, 2005

Ethics in medication-free research

Informed consent in medication-free schizophrenia research.
Moser DJ, Reese RL, Schultz SK, Benjamin ML, Arndt S, Fleming FW, Andreasen NC.
Am J Psychiatry. 2005 Jun;162(6):1209-11

To study schizophrenia without the influence of medications, some researchers conduct “medication-free schizophrenia research”. This involves recruiting medicated participants who go through a medication-free interval before the study and then go back to their medications after completing the study. Even though there are advantages to this type of research since it allows a relatively “pure” study of the illness, such studies have some ethical concerns. For example, what is the guarantee that someone who provides informed consent to participate at the beginning of a study doesn’t lose this capacity because of symptoms when medications are discontinued? So in the current study, Dr. Nancy Andreasen (a top schizophrenia researcher) and her group looked at whether the capacity for informed consent changes during the course of medication-free schizophrenia research.

Using questionnaires they measured 10 people with schizophrenia’s capacity for informed consent for research, neuropsychological or thinking performance, and psychiatric symptoms - before and after stopping antipsychotic medication. They found that participants showed very little change on most measures during the medication-free interval, although their ability to reason dropped significantly. Also, all those who showed a good understanding of study procedures at enrollment retained this capacity throughout the study. But they did find that reasoning scores declined significantly across the course of the medication-free interval.

Overall these results are encouraging since they show that people who decide to participate in medication-free schizophrenia research do not show a major decline in decisional capacity. So, once people decide to participate in this type of research, looks like they don’t change their ability to make the decision regarding participating in such research.

However, the decrease in reasoning ability found in this study is of concern. It highlights the need for more research on this topic to make sure the rights of participants are not violated. Particularly since this study was limited in only using 10 subjects and their medication-free interval of 2 weeks was quite brief (which is probably why they did not see any changes in the psychiatric symptoms upon discontinuing the medications). So with a longer medication-free interval and larger subjects there may be different findings – which is worthy of further investigation.

Click here to find this article on PubMed


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