Table 1 Subject selection issues identified across the CNS spectrum
All reviewed subjects | Challenged cases (% of all cases reviewed) | Not approved (% of all challenged cases) | ||
|---|---|---|---|---|
Inadequate documentation to support the diagnosis | 68 | 2.7% | 19 | 27.9% |
Insufficient symptom severity (too low) | 75 | 2.9% | 41 | 54.7% |
Symptom severity too high (above entry criteria) | 44 | 1.8% | 28 | 63.6% |
Presence of comorbid medical diagnosis | 30 | 1.2% | 5 | 16.6% |
Presence of comorbid psychiatric diagnosis | 67 | 2.7% | 29 | 43.3% |
Substance abuse/dependence | 29 | 1.2% | 12 | 41.4% |
External confounding factors | 50 | 1.9% | 11 | 22.0% |
Unreliable/unassessable subject or informant | 13 | 0.5% | 6 | 46.2% |
Other protocol-specific study criteria | 28 | 1.1% | 17 | 60.7% |
Total of all submitted subjects (n = 2,515) | 404 | 16.1% | 168 | 6.7% |