TABLE 1.
Algorithm for Continuation ECT in Phase 2 for the ECT Plus Medication Arm: Symptom-Titrated, Algorithm-Based Longitudinal ECT (STABLE)a
| Weeks 1–4: Fixed ECT schedule | |||
|---|---|---|---|
| One treatment 2–5 days after randomization, one treatment 7–12 days after randomization, one treatment 14–19 days after randomization, and one treatment 23–28 days after randomization (a total of four ECT treatments in 1 month) | |||
| Weeks 5–24: Symptom-Titrated ECT Schedule | |||
| Treatments per Week | Description | Corresponding HAM-D Condition | Relapse Potential |
| 0 | Current symptom level very low or Current symptom level low to moderate, with only small drift from baseline level or Last two HAM-D scores in remitted range with a flat trajectory (remission stable with less than 2-point change from previous) |
Current HAM-D score ≤6 Current HAM-D score 7–12 and is ≤2 points higher than baseline score Current HAM-D score 7–10 and previous score was 5–10 and current score is ≤2 points higher than previous score |
Low Low Low |
| 2 | Current symptom level very high or Current symptom level moderate to high, with trajectory increasing rapidly and large drift from baseline |
Current HAM-D score ≥16 Current HAM-D score 11–15, and current score is ≥3 points higher than previous score, and current score is ≥8 points higher than baseline score |
High High |
| 1 | Patients not requiring 0 or 2 treatments received 1 treatment | Current HAM-D score intermediate between criteria for low or high relapse potential | Moderate |
| Discontinue study | Current and previous HAM-D score ≥21, or the patient is suicidal, or the patient requires psychiatric hospitalization | ||
HAM-D=24-item Hamilton Depression Rating Scale.