Table 2.
Demographic and Clinical Features of the Total Continuation Trial Sample and for Each of the Four Randomized Treatment Groups.
| Variable | Total Continuation Sample | Phase 1: Placebo Phase 2: NT-Li |
Phase 1: Placebo Phase 2: VEN-Li |
Phase 1: NT Phase 2: NT-Li |
Phase 1: VEN Phase 2: VEN-Li |
|||||
|---|---|---|---|---|---|---|---|---|---|---|
|
| ||||||||||
| n=122 | n=20 | n=24 | n=39 | N=39 | ||||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | |
| Age (yr) | 48.90 | 15.01 | 48.30 | 16.76 | 45.50 | 9.86 | 47.08 | 16.79 | 53.13 | 14.38 |
| Gender (% female) | 64.75 | 65.00 | 58.33 | 58.97 | 74.36 | |||||
| Education, yr | 13.92 | 2.68 | 15.30 | 3.31 | 13.29 | 1.71 | 14.13 | 3.00 | 13.38 | 2.24 |
| PreECT HRSD | 29.80 | 5.80 | 30.30 | 5.71 | 28.17 | 5.25 | 31.36 | 6.49 | 28.97 | 5.19 |
| PreECT CGI [severity] | 5.30 | 0.71 | 5.30 | 0.47 | 5.33 | 0.70 | 5.49 | 0.60 | 5.10 | 0.88 |
| PreECT BDI | 37.24 | 10.60 | 39.75 | 8.80 | 34.92 | 10.02 | 40.33 | 10.68 | 34.28 | 10.88 |
| Psychotic (%) | 25.41 | 20.00 | 16.67 | 30.77 | 28.21 | |||||
| Polarity (% bipolar) | 19.67 | 30.00 | 20.83 | 28.21 | 5.13 | |||||
| Episode duration (wks.) § | 38.09 | 34.39 | 28.1 | 23.17 | 36.04 | 34.18 | 39.76 | 35.43 | 43.13 | 38.32 |
| Adequate antidepressant treatment trials, current episode (no.) | 1.21 | 1.29 | 1.45 | 1.00 | 1.54 | 1.69 | 0.95 | 1.05 | 1.15 | 1.33 |
| Total antidepressant treatment trials, current episode (no.) | 5.52 | 3.98 | 4.85 | 2.37 | 7.04 | 6.00 | 5.15 | 3.69 | 5.31 | 3.21 |
| Medication Resistant (%) | 75.41 | 85.00 | 75.00 | 71.79 | 74.36 | |||||
| Total ECT (no.) | 8.27 | 3.46 | 8.20 | 2.95 | 8.58 | 3.55 | 8.59 | 3.41 | 7.79 | 3.77 |
| PostECT HRSD | 5.43 | 2.78 | 6.50 | 2.86 | 5.25 | 2.27 | 5.18 | 2.99 | 5.23 | 2.79 |
| PostECT CGI [severity] | 1.82 | 0.83 | 1.90 | 1.02 | 1.97 | 0.81 | 1.58 | 0.74 | 1.94 | 0.80 |
| PostECT CGI [improvement] | 1.59 | 0.65 | 1.60 | 0.68 | 1.50 | 0.59 | 1.51 | 0.54 | 1.71 | 0.75 |
| PostECT BDI | 9.94 | 8.49 | 11.98 | 8.59 | 8.73 | 5.54 | 11.12 | 10.15 | 8.46 | 8.03 |
NT = Nortriptyline; VEN = Venlafaxine; Li = Lithium Carbonate; HRSD =Hamilton Rating Scale for Depression; CGI = Clinical Global Impression; BDI = Beck Depression Inventory-II.
Adequacy of each medication trial given during the index episode before ECT was evaluated with the Antidepressant Treatment History Form.14 Each trial was rated on a scale ranging from 0 to 5, with a score of 3 the threshold for classification as medication resistant. To be considered an adequate trial, the threshold for sufficient dosage corresponded, for example, to a minimum of 200 mg/d imipramine equivalents for tricyclic antidepressants and 20 mg/d for fluoxetine. The threshold for sufficient duration was a minimum of 4 weeks at or above the threshold for sufficient dosage. To be classified as resistant, patients with psychotic depression had to receive an adequate antidepressant trial and at least 3 weeks of concurrent treatment with an antipsychotic medication, with dosage at least 400 mg/d chlorpromazine equivalents.
An upper limit of 104 weeks was imposed.