Abstract
Objective. This randomized, 6-week, open-label study compared efficacy of CAD and antidepressant monotherapies (ADM) that had been chosen according to clinical judgment of the attending psychiatrist. Methods. A total of 60 inpatients (intent-to-treat analysis) with depressive disorder (≥ 1 unsuccessful antidepressant treatment) were randomly assigned to the interventions. The responders who completed the acute phase of study, were evaluated for relapse within 2 months of follow-up treatment. The primary outcome measure was change in the Montgomery–Åsberg Depression Rating Scale (MADRS) and response was defined as a ≥ 50% reduction of MADRS score. Results. Mean changes in total MADRS score from baseline to week 6 for patients in both treatment modalities were not different (ADM = 13.2 ± 8.6 points; CAD = 14.5 ± 9.5 points; P = 0.58). The analysis of covariance performed for significantly higher value of imipramine equivalent dose in CAD group showed only a non-significant between-group difference for total MADRS change (P = 0.17). There were also no differences between groups in response rate (ADM = 48%; CAD = 58%) and number of drop-outs in acute treatment as well as proportion of responders’ relapses in the follow-up. Conclusion. Both treatment modalities produced clinically relevant reduction of depressive symptomatology in acute treatment of patients with resistant depression and their effect was comparable.
Acknowledgements
The authors thank Ms Kveta Vonaskova and Ms Jolana Sediva for administrative and technical support.
Statement of Interest
This study was supported by a grant from Internal Grant Agency of Ministry of Health of Czech Republic No. NS 10368-3. MB, TN, PS, JC, JK and MK have no conflict of interest. CH: Clinical trials: coordinator of a multicentric study for Servier. Consultant: Advisory board member, Lilly and BMS. Grant: Lilly. Paid lectures for: Lilly, Janssen Cilag, BMS, Medicom, Nycomed, Krka. Other: faculty member, Lundbeck International Neuroscience Foundation.