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Practical clinical trials in psychopharmacology: a systematic review
#MMPMID25679131
Vitiello B
J Clin Psychopharmacol
2015[Apr]; 35
(2
): 178-83
PMID25679131
show ga
Practical clinical trials (PCTs) are randomized experiments under typical
practice conditions with the aim of testing the "real-life" benefits and risks of
therapeutic interventions. Influential PCTs have been conducted in cardiology,
oncology, and internal medicine. Psychotropic medications are widely and
increasingly used in medical practice. This review examines recent progress in
conducting PCTs in psychopharmacology. The January 2000 to October 2014 MEDLINE,
Scopus, and ClinicalTrials.gov databases were searched for peer-reviewed
publications of PCTs with at least 100 subjects per treatment arm. Most PCTs in
psychiatry evaluated mental health services or psychosocial interventions rather
than specific pharmacotherapies. Of 157 PCTs in psychiatry, 30 (19%) were in
psychopharmacology, with a median of 2 publications per year and no increase
during the period of observation. Sample size ranged from 200 to 18,154; only 11
studies randomized 500 patients or more. Psychopharmacology PCTs were equally
likely to be funded by industry as by public agencies. There were 10 PCTs of
antidepressants, for a total of 4206 patients (in comparison with at least 46
PCTs of antihypertensive medications, for a total of 208,014 patients). Some
psychopharmacology PCTs used suicidal behavior, treatment discontinuation, or
mortality as primary outcome and produced effectiveness and safety data that have
influenced both practice guidelines and regulatory decisions. Practical clinical
trials can constitute an important source of information for clinicians,
patients, regulators, and policy makers but have been relatively underused in
psychopharmacology. Electronic medical records and integrated practice research
networks offer promising platforms for a more efficient conduct of PCTs.
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