TY - JOUR
T1 - A comparison of nefazodone, the cognitive behavioral-analysis system of psychotherapy, and their combination for the treatment of chronic depression
AU - Keller, Martin B.
AU - McCullough, James P.
AU - Klein, Daniel N.
AU - Arnow, Bruce
AU - Dunner, David L.
AU - Gelenberg, Alan J.
AU - Markowitz, John C.
AU - Nemeroff, Charles B.
AU - Russell, James M.
AU - Thase, Michael E.
AU - Trivedi, Madhukar H.
AU - Zajecka, John
AU - Blalock, Janice A.
AU - Borian, Frances E.
AU - Jody, Darlene N.
AU - DeBattista, Charles
AU - Koran, Lorrin M.
AU - Schatzberg, Alan F.
AU - Fawcett, Jan
AU - Hirschfeld, Robert M.A.
AU - Keitner, Gabor
AU - Miller, Ivan
AU - Kocsis, James H.
AU - Kornstein, Susan G.
AU - Manber, Rachel
AU - Ninan, Philip T.
AU - Rothbaum, Barbara
AU - Rush, A. John
AU - Vivian, Dina
PY - 2000/5/18
Y1 - 2000/5/18
N2 - Background: Patients with chronic forms of major depression are difficult to treat, and the relative efficacy of medications and psychotherapy is uncertain. Methods: We randomly assigned 681 adults with a chronic nonpsychotic major depressive disorder to 12 weeks of outpatient treatment with nefazodone (maximal dose, 600 mg per day), the cognitive behavioral-analysis system of psychotherapy (16 to 20 sessions), or both. At base line, all patients had scores of at least 20 on the 24-item Hamilton Rating Scale for Depression (indicating clinically significant depression). Remission was defined as a score of 8 or less at weeks 10 and 12. For patients who did not have remission, a satisfactory response was defined as a reduction in the score by at least 50 percent from base line and a score of 15 or less. Raters were unaware of the patients' treatment assignments. Results: Of the 681 patients, 662 attended at least one treatment session and were included in the analysis of response. The overall rate of response (both remission and satisfactory response) was 48 percent in both the nefazodone group and the psychotherapy group, as compared with 73 percent in the combined-treatment group (P<0.001 for both comparisons). Among the 519 subjects who completed the study, the rates of response were 55 percent in the nefazodone group and 52 percent in the psychotherapy group, as compared with 85 percent in the combined-treatment group (P<0.001 for both comparisons). The rates of withdrawal were similar in the three groups. Adverse events in the nefazodone group were consistent with the known side effects of the drug (e.g., headache, somnolence, dry mouth, nausea, and dizziness). Conclusions: Although about half of patients with chronic forms of major depression have a response to short-term treatment with either nefazodone or a cognitive behavioral-analysis system of psychotherapy, the combination of the two is significantly more efficacious than either treatment alone. (C) 2000, Massachusetts Medical Society.
AB - Background: Patients with chronic forms of major depression are difficult to treat, and the relative efficacy of medications and psychotherapy is uncertain. Methods: We randomly assigned 681 adults with a chronic nonpsychotic major depressive disorder to 12 weeks of outpatient treatment with nefazodone (maximal dose, 600 mg per day), the cognitive behavioral-analysis system of psychotherapy (16 to 20 sessions), or both. At base line, all patients had scores of at least 20 on the 24-item Hamilton Rating Scale for Depression (indicating clinically significant depression). Remission was defined as a score of 8 or less at weeks 10 and 12. For patients who did not have remission, a satisfactory response was defined as a reduction in the score by at least 50 percent from base line and a score of 15 or less. Raters were unaware of the patients' treatment assignments. Results: Of the 681 patients, 662 attended at least one treatment session and were included in the analysis of response. The overall rate of response (both remission and satisfactory response) was 48 percent in both the nefazodone group and the psychotherapy group, as compared with 73 percent in the combined-treatment group (P<0.001 for both comparisons). Among the 519 subjects who completed the study, the rates of response were 55 percent in the nefazodone group and 52 percent in the psychotherapy group, as compared with 85 percent in the combined-treatment group (P<0.001 for both comparisons). The rates of withdrawal were similar in the three groups. Adverse events in the nefazodone group were consistent with the known side effects of the drug (e.g., headache, somnolence, dry mouth, nausea, and dizziness). Conclusions: Although about half of patients with chronic forms of major depression have a response to short-term treatment with either nefazodone or a cognitive behavioral-analysis system of psychotherapy, the combination of the two is significantly more efficacious than either treatment alone. (C) 2000, Massachusetts Medical Society.
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U2 - 10.1056/NEJM200005183422001
DO - 10.1056/NEJM200005183422001
M3 - Article
C2 - 10816183
AN - SCOPUS:0034682305
SN - 0028-4793
VL - 342
SP - 1462
EP - 1470
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 20
ER -