Table 1.
Scientific Designs and Procedures
| Theme | Article Type and N (if applicable) | Major Findings |
| Placebo-controlled studies | • Meta-analyses91,92 | • No conclusive evidence for higher rates of attempted or completed suicide in patients randomized to placebo vs. active drug, based on Food and Drug Administration database91 and on over 10 years of data in Netherlands.92 |
| • Review and commentary | • The exclusion in most trials of patients with suicidality limits generalizability to people who would typically be eligible for these kinds of studies.69 | |
| Medication-free intervals | • Survey study involving hypothetical scenario with washout phase and symptom reemergence; N = 59 pts with SCZ and 70 psychiatrists | • Both groups rated protocol as moderately harmful, expressing low likelihood of willingness to participate (given described symptom reemergence). Most respondents (63% of pts and 52% of psychiatrists) stated view that study participant's objection to medication being given should be overridden; psychiatrists incorrectly thought that patients would be less supportive of involuntary medication in this context.88 |
| • See also Moser et al. 2005,87 described in Table 2, regarding stability of decision-making abilities during medication-free period. | ||
| Views of pts regarding placebo- controls and medication washouts | • Survey study using hypothetical study vignettes; N = 59 pts with SCZ and 70 psychiatrists | • Patients able to distinguish among protocols of varying levels of potential harm, viewing washout and placebo-controlled studies as having potentially more harm vs. medication trial (without placebo) or blood draw.123 |
| Understanding of placebo controls | • Hypothetical clinical trial consent; N = 49 pts with SCZ | • Cognitive deficits, negative symptoms, and worse performance on MacCAT-CR Understanding and Reasoning subscales (but not general psychopathology or positive symptoms) associated with worse performance on questionnaire assessing understanding of placebos (see Dunn, Palmer, and Keehan,171 in this issue). |
| Views of genetic research | • Survey study; N = 60 employees at scientific lab and academic health center | • Respondents strongly supported value of conducting genetic research on both serious mental and physical illnesses.115 |
| • Respondents also viewed genetic information as more sensitive and requiring greater protection than other forms of health-related data; overall, rated as moderately likely specific negative consequences of disclosure of genetically related illness risk (eg, increased insurance expenses, uninsurability, loss of employment, diminished future work opportunities).116 | ||
| Prodromal/first episode schizophrenia research | • Review articles and commentaries | • Important ethical issues exist,96 yet have received minimal empirical attention. Rates of conversion from at-risk to frank psychosis seem to vary from study to study.93, 95 |
| • Survey of relatives (N = 200) | • 85% would have visited early detection clinic earlier, 79% preferred to find out earlier.98 | |
| • Focus group (N = 12) | • First-episode patients preferred close clinician contact, involvement in ongoing decision making.100 | |
| • Survey of first-episode patients (N = 59) | • Side-effects, lack of social activities, male sex, and young age correlated with noncompliance during first-episode psychosis.99 |
Note: Abbreviations used: MacCAT-CR = MacArthur Competence Assessment Tool for Clinical Research;146 pts = patients; SCZ = schizophrenia. Unless otherwise specified, “patients” refers to patients with schizophrenia.