Self-Rated Functional Measures Informative for Inadequate Response Patients with MDD

Following their review, the authors concluded that the SDS reports are useful in informing acute randomized placebo-controlled studies.

A recent systematic review of literature looked at self-rated functional measures in patients with major depressive disorder (MDD) who had insufficient response to antidepressant treatment, finding that the self-rating Sheehan Disability Scale (SDS) is informative enough, however, may be less relevant than measures of social and family life.

The goal of the review was to determine if these self-rated reports are useful in randomized, placebo-controlled study of adjunctive therapy in these patients. Antidepressant therapy includes treatment with selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, other antidepressants, and psychotherapies including cognitive behavior therapy.

“Patients with MDD typically have impaired functioning across multiple domains, including work, social, and family functioning,” the authors wrote. “For example, depres­sive symptoms are associated with reduced marital quality, reduced work performance, and lower earnings. Patients with MDD consider a return to normal levels of functioning as one of the most important factors in defining remission from depression.”

They also noted that more than half of patients who have MDD are unresponsive to treatment with antidepressants, which can result in longer periods of functional loss and lower likelihood of employment. According to the authors, “studies have shown that people with depression who are in employment are less severely ill than those who are unemployed.”

Researchers reviewed and extracted characteristics and efficacy data from 293 articles and 26 studies taken from MEDLINE from January 1990 through March 2017. These studies were all of patients with MDD who had an inadequate response to treatment with at least one method of antidepressant therapy, who had also attempted pharmacological or other adjunctive therapy. The studies were randomized controlled or post hoc analyses of randomized controlled, with a placebo control group, and they all used the self-rating Sheehan Disability Scale (SDS).

The authors wrote: “The SDS appears to be the most widely used functioning measure in studies of MDD [and] is considered a reliable and valid measure of functioning impairment, originally developed in 1981 for use in treatment outcome studies in psychiatry.” It examines work/school, social, and family life, and incorporates “other impairment instruments” and patient/colleague input.

The authors wrote, “In general, all 3 items, including the work/studies item, are sensitive to treatment effects across a variety of psycho­logical disorders. With the exception of 1 study that ran for 52 weeks, the studies were all acute, lasting 6 to 12 weeks.

According to the published results: “Of the 13 adjunctive agents identified, aripiprazole, brexpiprazole, edivoxetine, and risperidone improved functioning versus placebo (P <.05), as measured by the SDS total or mean score. On the SDS work/studies item, only aripiprazole had a statistically significant benefit, in 1 study out of 4. Thus, where a benefit was observed on the SDS total or mean, this was generally driven by improvement on the ‘social life’ and ‘family life’ items.” For this specific population, the authors added that the social and family life measures may be more relevant than the work performance measure.

The authors noted that limitations of their review being that it only incorporated published data taken from only one database (MEDLINE) and that studies may have been too short to demonstrate any benefit.

Following their review, the authors concluded that the SDS reports are useful in informing acute randomized placebo-controlled studies.

The full review, “Functioning outcomes with adjunctive treatments for major depressive disorder: a systematic review of randomized placebo-controlled studies,” was published in Neuropsychiatric Disease and Treatment.

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