Table 8.
Number of Patients Reporting Any Suicidal Ideation and/or Behavior by Treatment, Phase
| Group | Phase1 | Number of patients with suicidal ideation and/or behavior | Number of patients with clinically significant 2 suicidal ideation and/or behavior |
|---|---|---|---|
| Screen only (Non Randomized) (N=121)3 | Total | 20 | 0 |
| Group A:A:A:A (N = 27) | Total | 12 | 0 |
| A:A:A:A | Screening | 10 | 0 |
| A:A:A:A | Treatment period 1 | 11 | 0 |
| A:A:A:A | Treatment period 2 | 8 | 0 |
| A:A:A:A | Follow-Up | 7 | 0 |
| Group S:S:S:S (N = 29) | Total | 15 | 0 |
| S:S:S:S | Screening | 9 | 0 |
| S:S:S:S | Treatment period 1 | 10 | 0 |
| S:S:S:S | Treatment period 2 | 8 | 0 |
| S:S:S:S | Follow-Up | 14 | 0 |
| Group S:S:A:A (N = 29) | Total | 17 | 0 |
| S:S:A:A | Screening | 10 | 0 |
| S:S:A:A | Treatment period 1 | 12 | 0 |
| S:S:A:A | Treatment period 2 | 7 | 0 |
| S:S:A:A | Follow-Up | 12 | 0 |
| All Groups (N = 206) | Total | 64 | 0 |
Unit of observation is subject. Some subjects have multiple events.
Screening Phase (before treatment): 7–14 days. Treatment Phase: Divided into 2 treatment periods of 2 days of treatment each (period 1 includes Day 0 and 1, period 2 includes Day 2 and 3). During the Treatment Phase, patients are assigned to one of 3 arms for the two periods: Active/Active, Sham/Active or Sham/Sham. Follow-up Phase: weekly for 28 days, starting with Day 4.
As indicated and justified on the SIB-Q
Including only screen-failures who completed the clinical interview (e.g., a patient screened out for hypertension would not necessarily complete a clinical interview)
Note: 1 SIBQ report is missing: 205-013 Day 4