Is bigger better for depression trials?

• Published in: Journal of psychiatric research Vol. 42; no. 8; pp. 622 - 630
• Main Authors: Liu, Kenneth S., Snavely, Duane B., Ball, William A., Lines, Christopher R., Reines, Scott A., Potter, William Z.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.07.2008; Elsevier
• Subjects: Adult; Biological and medical sciences; Clinical trial; Clinical Trials, Phase III as Topic - statistics & numerical data; Depression; Depressive Disorder - drug therapy; Double-Blind Method; Female; Humans; Male; Medical sciences; Methodology. Experimentation; Neuropharmacology; Paroxetine; Paroxetine - therapeutic use; Patient Selection; Pharmacology. Drug treatments; Placebo; Placebos; Psychiatry; Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer; Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer..., (alzheimer disease); Psychology. Psychoanalysis. Psychiatry; Psychopathology. Psychiatry; Psychopharmacology; Randomized Controlled Trials as Topic - methods; Randomized Controlled Trials as Topic - statistics & numerical data; Sample Size; Serotonin Uptake Inhibitors - therapeutic use; Techniques and methods; Time Factors; Treatment effect; Treatment Outcome; Paroxetine; Depression; Clinical trial; Sample size; Placebo; Treatment effect; Mood disorder; Human; Evaluation; Protocols; Serotonin; Methodology; Psychotropic; Multicenter study; Pharmacotherapy; Controlled therapeutic trial; Reuptake inhibitor; Selective serotonin reuptake inhibitor; Treatment; Piperidine derivatives; Neurotransmitter; Antidepressant agent; Comparative study

A key assumption underlying the principle that power increases with sample size is that the standardized effect size is fixed over time. In therapeutic areas where it may be difficult to continually recruit from a homogeneous population, this assumption may not be valid; patients randomized toward t...