Uncontrolled Variables in Psychiatric Clinical Drug Trials

Medication Adherence and Compliance Uncontrolled variables in psychiatric clinical drug trials According to Griswold, Murray & Corrado (2012), one troubling aspect of psychotropic drug clinical trials is the lack of controls for subjects' adherence to medication protocols. Psychiatric patients in particular have historically been noted to have relatively low levels of compliance. In general, "as drug dosages increase, treatment adherence decrease" because of intensification of symptoms, difficulty remembering dosages, and other issues (Griswold, Murray & Corrado 2012).

Under-medicating or discontinuing medications is common in schizophrenic and bipolar patients, due to reasons such as "perceived or real decreases in disease progression or symptomatology, perceived helplessness, defense mechanisms such as denial, motivational apathy, and lack of family or financial support"(Griswold, Murray & Corrado 2012). For potentially addictive substances such as stimulants and opioids, over-medication is a greater risk. The study specifically took the form of a literature review. The authors conducted a search using clinical drug trials from PubMed / Medline, Science Direct, Scirus, and Scopus from 2002-2012.

All trials used human subjects. Studies were examined to see if controls for subject adherence were conducted. In the seven categories of drug types of (1) antidepressants, (2) antipsychotics, (3) anticonvulsants, (4) anxiolytics, (5) stimulants, (6) opioids, and (7) mood stabilizers), "67% of articles on clinical drug trials neglected to mention or control for compliance" (Griswold, Murray & Corrado 2012). Searches for controls for compliance were based upon the wording in the article.

"It is our assumption that if authors of published clinical trial studies, in peer-reviewed journals, attempted to control for adherence or compliance, the word itself (adherence or compliance) would be mentioned somewhere in the anatomy of the publications" (Griswold, Murray & Corrado 2012). The different drugs in the different search engines were with paired in separate searches for the key words "adherence" and "compliance." The overall finding of the article was a troubling lack of control for adherence to the study protocols by psychiatric subjects.

"The evidence suggests that medication adherence in medical research is not a formally assessed variable; neither is it mentioned in the majority of publications available through popular electronic and scientific databases" (Griswold, Murray & Corrado 2012). Of course, the most obvious limitation of this study is that the drug studies' designers may have included controls for compliance but simply did not 'spell them out' in the discussion of the results.

There is the possibility that compliance was discussed or controlled for, but simply phrased in a different manner by the research subjects. Also, a fairly limited range of databases was selected. The study is valuable given the need for accuracy in studies of psychotropic drugs in.