By Robert Whitaker
August 13, 2022
Source: Mad in America
Photo / Image Source: Unsplash,
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Studies in “real-world” patients
The industry-funded trials are typically conducted in a subset of patients who could be expected most likely to respond well to the drug (without comorbidities and so forth), and thus are understood to not necessarily reflect outcomes in the general population. Studies in “real-world” patients, which in the U.S. are usually funded by the National Institute of Mental Health, are typically not placebo-controlled, but rather simply seek to assess what percentage of patients respond, in a significant way, to the treatment.
These studies have reported lower “response” rates to antidepressants than the industry-funded trials do, and particularly poor stay-well rates.
In a 2004 study of 118 real-world patients treated with an antidepressant, only 26% of the patients “responded” to the treatment (meaning that their symptoms decreased at least 50% on a rating scale), and fewer than 13% were in remission at the end of 12 months. These findings, the investigators concluded, “reveal remarkably low response and remission rates.”
The STAR*D trial funded by the NIMH, which was heralded as the largest antidepressant trial ever conducted, produced similarly poor results in “real-world” patients. The 4,041 patients enrolled into the trial were given up to four trials on an antidepressant to find one that led to remission (defined as a score below 7 on the Hamilton scale), and only 38% achieved this level of improvement.
Those who remitted were then whisked into a longer-term follow-up study, where they would get the best clinical care possible. Yet, at the end of one year, only 108 of the 4,041 patients entered into the STAR*D trial had remitted, and then stayed well and in the trial to its end. All the rest had either never remitted, relapsed, or dropped out at some point. That is a one-year stay-well rate of 3%.
More recently, an international group of researchers, in a study of 1,217 patients diagnosed with major depressive disorder, reported that only 24% responded to treatment with an antidepressant (either alone or in combination with psychotherapy.) Thirty-four percent were “non-responders” to antidepressants, and the remaining 41% fared so poorly that they were deemed “treatment resistant.” Nearly 60% ended up ended up on multiple medications, including multiple antidepressants, antipsychotics, benzodiazepines, and other combinations of drugs.
These real-world studies were not placebo controlled, and thus there wasn’t a comparison with a similar group of untreated patients. This raises the obvious question: What is the natural course of depression?
Prior to the antidepressant era, depression was understood to be an episodic disorder, as opposed to a chronic illness. Spontaneous recovery rates were said to exceed 50% within a few months, with this recovery rate reaching 85% or so by the end of one year. As Dean Schuyler, head of the depression section at the NIMH explained in a 1974 book, most depressive episodes “run their course and terminate with virtually complete recovery without specific intervention.”12
However, after the introduction of antidepressants, the disorder began running a much more chronic course. In the 1970s, several clinicians observed that the drug was causing a “chronification” of the disease, and subsequent epidemiological studies confirmed that the long-term course of depression had changed. The APA’s 1999 textbook summed up the findings from the newer studies: “Only 15% of people with unipolar depression experience a single bout of the illness,” and for the remaining 85%, with each new episode, remission becomes “less complete and new recurrences develop with less provocation.”13
With the outcomes for medicated patients so poor, the NIMH funded a study to assess the course of “untreated depression” in the modern era. Perhaps the natural course of depression had changed? In 2006, researchers reported that 23% of the non-medicated patients recovered in one month; 67% in six months; and 85% within a year. These were outcomes, the researchers concluded, that echoed those in the pre-antidepressant era. “If as many as 85% of depressed individuals who go without somatic treatment spontaneously recover within one year, it would be extremely difficult for any intervention to demonstrate a superior result to this,” they wrote.
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