Symptomatic volunteers in multicenter drug trials

Area of Science:

• Psychiatry
• Clinical Psychology
• Pharmacology

Background:

• Recruitment for anxiety and antidepressant drug trials is challenging due to a diminishing pool of outpatients.
• Identifying and enrolling suitable participants who meet specific inclusion/exclusion criteria can be difficult.

Purpose of the Study:

• To assess the feasibility of recruiting symptomatic volunteers for anti-anxiety and antidepressant drug trials.
• To evaluate the characteristics and retention of symptomatic volunteers compared to traditional outpatient recruitment.

Main Methods:

• Volunteers with significant anxiety or depression symptoms, not currently in treatment, were recruited via advertisements at two institutions.
• Rigorous screening ensured participants met distress severity criteria and had no medical contraindications.
• Demographic characteristics, distress levels, and symptom duration were analyzed for sample homogeneity.

Main Results:

• Adequate numbers of symptomatic volunteers were successfully recruited, meeting stringent criteria.
• Homogeneity was observed across samples from collaborating institutions regarding demographics and symptom profiles.
• Attrition rates for symptomatic volunteers were lower than those typically seen in outpatient drug trials.

Conclusions:

• Symptomatic volunteers represent a feasible and effective alternative recruitment pool for psychiatric drug trials.
• This approach can help overcome challenges associated with declining outpatient participation.
• The findings support the use of symptomatic volunteers in clinical research for anxiety and depression treatments.