Randomized Controlled Trial to Determine the Clinical and Cost Effectiveness of Selective Serotonin Reuptake Inhibitors Plus Supportive Care, Versus Supportive Care Alone, for Mild to Moderate Depression with Somatic Symptoms in Primary Care.
Aim: To determine whether treatment with a selective serotonin reuptake inhibitor (SSRI) antidepressant is effective and cost effective for mild to moderate depression in primary care. Secondary aims were: to explore whether treatment is more effective for moderate depression than for mild; and explore patient factors that might predict outcome, and/or predict a beneficial response to antidepressants.
Conclusions and results: More than 90% of patients in each arm received supportive care from the general practitioners (GPs), with a mean number of consultations of around 4 during the 12-week treatment period. SSRI antidepressants were received by 87% of patients in the SSRI plus supportive care arm, and also by 20% of patients in the supportive care alone arm. Longitudinal analyses demonstrated statistically significant differences in favor of the SSRI plus supportive care arm in terms of lower Hamilton Depression Rating Scale (HDRS) scores, higher scores on the SF-36 mental health subscale, and higher scores on the MISS, but not in terms of lower Beck Depression Inventory (BDI) scores. Significant mean differences in HDRS score adjusted for baseline were found at both follow-up points when analyzed separately, but were relatively small: 2.3 points at 12 weeks and 1.7 points at 26 weeks. The number needed to treat (NNT) for remission (to HDRS < 8) was 6 (95% CI 4 to 26) at 12 weeks and 6 (3 to 31) at 26 weeks, and the NNTs for significant improvement (HDRS fall of >=50%) were 7 (4 to 83) and 5 (3 to 13) respectively. Costs were slightly higher in the SSRI plus supportive care arm, but not significantly different.
Recommendations: See Executive Summary link at www.ncchta.org/project/1356.asp.
Methods: See Executive Summary link at www.ncchta.org/project/1356.asp.
Further research/reviews required: More studies of drug and nondrug treatments for mild depression in primary care are needed, as the evidence base for the treatment of mild depression is still relatively small. More research is needed on the natural history of mild to moderate depression and predictors of chronicity because, although many patients recover within weeks without treatment, a significant number do not improve over 6 months of follow-up. More research is needed to identify the most effective elements of supportive care. More research is needed into the differences between the HDRS, BDI, and other measures of depression, to explore whether they measure different aspects of depression and differ in sensitivity to change in relation to drug, psychological, and other treatments. Better measures of outcome for depression studies need to be developed, including patient-derived measures.
Written by: Mrs Judy Chatwin, University of Southampton, NETSCC, United Kingdom