Livia Hartmann Souza1, Giovanni Abrahão Salum2, Bruno Paz Mosqueiro3, Marco Antonio Caldieraro3, Tadeu Assis Guerra4, Marcelo P Fleck3. 1. Mood Disorders Outpatient Program, PROTHUM, Federal University of Rio Grande do Sul, UFRGS/Hospital de Clínicas de Porto Alegre, HCPA, Porto Alegre, Brazil; Post Graduate Program in Medical Sciences: Psychiatry, Federal University of Rio Grande do Sul, UFRGS, Porto Alegre, Brazil. Electronic address: liviahartmanndesouza@gmail.com. 2. Post Graduate Program in Medical Sciences: Psychiatry, Federal University of Rio Grande do Sul, UFRGS, Porto Alegre, Brazil; Anxiety Disorders Outpatient Program for Children and Adolescents, PROTAIA, Federal University of Rio Grande do Sul, UFRGS/Hospital de Clínicas de Porto Alegre, HCPA, Porto Alegre, Brazil; National Institute of Developmental Psychiatry for Children and Adolescents (INPD/ CNPq), Brazil. 3. Mood Disorders Outpatient Program, PROTHUM, Federal University of Rio Grande do Sul, UFRGS/Hospital de Clínicas de Porto Alegre, HCPA, Porto Alegre, Brazil; Post Graduate Program in Medical Sciences: Psychiatry, Federal University of Rio Grande do Sul, UFRGS, Porto Alegre, Brazil. 4. Mood Disorders Outpatient Program, PROTHUM, Federal University of Rio Grande do Sul, UFRGS/Hospital de Clínicas de Porto Alegre, HCPA, Porto Alegre, Brazil; Federal University of Rio Grande do Sul, UFRGS, Porto Alegre, Brazil.
Abstract
BACKGROUND: Treatment-resistant depression (TRD) is an extremely prevalent clinical condition. Although Interpersonal Psychotherapy (IPT) is an established treatment for uncomplicated depression, its effectiveness has never before been studied in patients with TRD in real-world settings. We investigate IPT as an adjunct strategy to treatment as usual (TAU) for TRD patients in a pragmatic, randomized, controlled trial. METHODS: A total of 40 adult patients with TRD (satisfying the criteria for major depressive disorder despite adequate antidepressant treatment) were recruited from a tertiary care facility for this pragmatic trial and blinded to the evaluator. Patients were randomized to one of two treatment conditions: (1) TAU - pharmacotherapy freely chosen by the clinician (n=23) and (2) TAU+IPT (n=17). Assessments were performed at weeks 8, 12, 19 and 24. Changes in the estimated means of the Hamilton Depression Rating Scale score were the primary outcome measure. Secondary outcomes included patient-rated scales and quality of life scales. We used a linear mixed model to compare changes over time between the two groups. RESULTS: Both treatments lead to improvements in depressive symptoms from baseline to week 24 with no significant between group differences in either primary: TAU (mean difference: 4.57; CI95%: 0.59-8.55; d=0.73) vs. IPT+TAU (mean difference: 5.86, CI95%: 1.50-10.22; d=0.93) or secondary outcomes. LIMITATIONS: Our relatively small sample limits our ability to detect differences between treatments. CONCLUSIONS: Both treatments lead to equal improvements in depressive symptoms. We found no evidence to support adding IPT to pharmacotherapy in patients with TRD. TRIAL REGISTRATION: ClinicalTrials.gov-NCT01896349.
RCT Entities:
BACKGROUND: Treatment-resistant depression (TRD) is an extremely prevalent clinical condition. Although Interpersonal Psychotherapy (IPT) is an established treatment for uncomplicated depression, its effectiveness has never before been studied in patients with TRD in real-world settings. We investigate IPT as an adjunct strategy to treatment as usual (TAU) for TRD patients in a pragmatic, randomized, controlled trial. METHODS: A total of 40 adult patients with TRD (satisfying the criteria for major depressive disorder despite adequate antidepressant treatment) were recruited from a tertiary care facility for this pragmatic trial and blinded to the evaluator. Patients were randomized to one of two treatment conditions: (1) TAU - pharmacotherapy freely chosen by the clinician (n=23) and (2) TAU+IPT (n=17). Assessments were performed at weeks 8, 12, 19 and 24. Changes in the estimated means of the Hamilton Depression Rating Scale score were the primary outcome measure. Secondary outcomes included patient-rated scales and quality of life scales. We used a linear mixed model to compare changes over time between the two groups. RESULTS: Both treatments lead to improvements in depressive symptoms from baseline to week 24 with no significant between group differences in either primary: TAU (mean difference: 4.57; CI95%: 0.59-8.55; d=0.73) vs. IPT+TAU (mean difference: 5.86, CI95%: 1.50-10.22; d=0.93) or secondary outcomes. LIMITATIONS: Our relatively small sample limits our ability to detect differences between treatments. CONCLUSIONS: Both treatments lead to equal improvements in depressive symptoms. We found no evidence to support adding IPT to pharmacotherapy in patients with TRD. TRIAL REGISTRATION: ClinicalTrials.gov-NCT01896349.
Authors: Maria Isabel Perez Mattos; Bruno Paz Mosqueiro; Scott Stuart; Giovanni Salum; Rosana de Lima Duzzo; Laura Wolf de Souza; Ariane Chini; Marcelo Pio de Almeida Fleck Journal: Rev Saude Publica Date: 2022-04-22 Impact factor: 2.106