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. Author manuscript; available in PMC: 2023 Oct 12.
Published in final edited form as: N Engl J Med. 2023 Mar 3;388(12):1067–1079. doi: 10.1056/NEJMoa2204462

Table 1.

Demographic and Clinical Characteristics of the Patients at Baseline.*

Characteristic Step 1 Step 2
Aripiprazole-Augmentation Group (N = 211) Bupropion-Augmentation Group (N = 206) Switch-to-Bupropion Group (N = 202) Lithium-Augmentation Group (N = 127) Switch-to-Nortriptyline Group (N = 121)
Age — yr 69.1±6.5 69.1±7.1 69.7±7.7 69.0±6.0 68.0±5.7
Female sex — no. (%) 144 (68.2) 142 (68.9) 127 (62.9) 90 (70.9) 83 (68.6)
Race — no. (%)
 White 173 (82.0) 174 (84.5) 175 (86.6) 116 (91.3) 106 (87.6)
 Black 16 (7.6) 17 (8.3) 13 (6.4) 7 (5.5) 4 (3.3)
 Other 22 (10.4) 15 (7.3) 14 (6.9) 4 (3.1) 11 (9.1)
Ethnic group — no. (%)
 Hispanic or Latino 22 (10.4) 17 (8.3) 13 (6.4) 3 (2.4) 10 (8.3)
 Other 189 (89.6) 189 (91.7) 189 (93.6) 124 (97.6) 111 (91.7)
Education
 No. of patients evaluated 208 203 198 121 120
 Mean — yr 14.4±3.0 14.4±3.0 15.1±2.8 15.3±2.6 14.6±2.8
PHQ-9 score 16.2±4.2 15.9±4.1 15.2±4.4 14.4±4.3 14.4±4.4
No. of adequate trials of antidepressant treatment§ 2.3±0.8 2.2±0.7 2.4±0.9 2.5±0.9 2.6±1.1
Age at first onset of MDD
 No. of patients evaluated 192 182 186 101 103
 Mean — yr 30.5±19.1 34.5±21.3 33.0±20.3 30.3±18.8 29.0±19.3
CIRS-G total score
 No. of patients evaluated 207 206 201 127 121
 Mean score 8.8±4.9 8.7±4.7 8.7±4.7 8.3±4.4 8.1±4.1
Falls during past 6 mo — no./total no. (%)
 0 117/208 (56.2) 130/204 (63.7) 117/199 (58.8) 76/127 (59.8) 79/120 (65.8)
 ≥1 91/208 (43.8) 74/204 (36.3) 82/199 (41.2) 51/127 (40.2) 41/120 (34.2)
*

Plus–minus values are means ±SD. Percentages may not total 100 because of rounding. MDD denotes major depressive disorder.

Race and ethnic group were reported by the patients.

Scores on the nine-item Patient Health Questionnaire (PHQ-9) range from 0 to 27, with higher scores indicating greater severity of symptoms.

§

Adequate trials met criteria for minimal adequate dose and treatment duration. Psychotherapy treatment was not considered to indicate a failed antidepressant trial. Data were collected at trial entry; for step 2 patients, the trial drugs received in step 1 were not included.

The Cumulative Illness Rating Scale–Geriatric (CIRS-G) instrument captures information about the severity of physical problems divided into 14 categories based on body system (e.g., vascular, renal, and neurologic). Ratings for the severity of each category range from 0 to 4, with higher scores indicating greater severity. Scores for each category are added to calculate the total score (range, 0 to 56).