Anxiety Clinical Trials May Not Provide Representative Sample
the Psychiatry Advisor take:
Pharmacological and pharmacotherapy clinical trials may not yield representative results as too many patients are excluded from the studies.
Nicholas Hoertel, MD, MPH, of the French Institute of Health and Medical Research in Paris, and colleagues, examined data from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions, which includes more than 34,000 adults. Their goal was to assess how many participants with social anxiety disorder (SAD) would fulfill typical eligibility criteria.
More than seven of 10 respondents from the overall SAD sample in a typical pharmacological efficacy trial and more than six of 10 participants in a typical psychotherapy efficacy trial would have been excluded by at least one criterion, the researchers reported in the Journal of Clinical Psychopharmacology. Most of the ineligibility was related to participants having depression.
Also, more than 80% of respondents seeking treatment for SAD would have been excluded from participation in a typical pharmacological or psychotherapy efficacy trial.
“Clinical trials should carefully consider the impact of exclusion criteria on the generalizability of their results and explain the rationale for their use,” the researchers concluded. “For SAD treatment trials to adequately inform clinical practice, the eligibility rate must be increased through a general relaxation of overly stringent eligibility criteria.”
Clinical Trials for Anxiety May Not Provide Representative Sample
Sign Up for Free e-newsletters
Psychiatry Advisor Articles
- Role of Expressed Emotion in Family Psychopathology
- Serum Uric Acid May Predict Bipolar Disorder in Patients With Depression
- Health and Social Factors Predict Changes in Depressive Symptoms in Women
- ASD Risk on Offspring With Prenatal Use of Medication Affecting Neurotransmitter System
- Group Cognitive Behavioral Therapy Is Effective Treatment for Adolescent Anxiety
- Cannabis Use in Adolescence Associated With Poorer Mental Health Outcomes
- Cannabis Use, Cannabis Use Disorder Linked to Psychotic, Depressive Symptoms
- Association Between Opioid and Benzodiazepine Misuse and Suicidal Ideation
- The Intersection of Eating and Alcohol Disorders: Detecting and Managing "Drunkorexia"
- Heart Rate Variability Predicts Treatment Response in Anxious Depression
- Abstinence From Regular Cannabis Use Improves Memory Among Adolescents, Young Adults
- Effects of Mindfulness Meditation on Mood in Middle-Age, Older Adults
- How Does Accepting Blame Affect Future Medical Errors?
- Dementia Often Misclassified With Brief Cognitive Assessments
- Vitamin D Deficiency May Contribute to Elevated Interleukin-6 in Psychosis