Can we identify patients for whom immediate medication prescription may be unnecessary

A common design feature is a 7- to 10-day single-blind initial placebo run-in period ( IPR) prior to a double-blind phase. The purpose of the IPR is to remove patients with an increased chance of placebo effect. Typically, much improved patients do not enter a double-blind phase, but minimally improved patients continue into the double-blind phase. We found that patients minimally improved during a single-blind placebo period had a better prognosis whether subsequently assigned to drug or placebo.(33) This was an unexpected post hoc finding, and therefore should be viewed cautiously. However, in this sample of 593 patients, there was a consistent trend across a range of diagnosis, severity, and chronicity for patients minimally improved after IPR to have a more favourable prognosis. The prognosis of minimally improved patients was almost 20 per cent better than those unimproved after iPr, whether the patient received drug or placebo. The relevance of this difference is put in perspective if we consider that the effect size of antidepressants is of the order of 30 to 40 per cent.

Tabled characterizes the course of patients minimally improved after IPR, and subsequently randomized to 6 weeks of placebo. To estimate the morbidity experienced by these 49 patients, their six study weeks are stratified by the number of weeks their symptoms remained minimally improved (or much improved) versus returned to baseline severity. Approximately half these patients were at least minimally improved for most of the study, with zero or one of six study weeks in which symptoms returned to baseline severity, and at the study end 79 per cent (19/24) were rated responders. Minimally improved patients randomized to placebo who had two or more unimproved weeks had only an 8 per cent (2/25) chance of being rated a responder at the study end. A comparison of those with 1 or less versus 2 or more weeks (out of 6 weeks) with symptoms at baseline severity suggests the former have a much better chance of being rated a responder at week 6 (c2 = 25.32, df = 1, p <; 0.001). These data suggest that some patients who were minimally improved after initial treatment contact should only receive drug if their symptoms return to baseline severity for more than 1 week.

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Table 2 Course of patients minimally improved after an IPR who were assigned to placebo for 6 weeks (n = 49)

Since 26 per cent (154/593) of the patients were minimally improved after an IPR, and 49 per cent (24/49) on placebo had a relatively asymptomatic double-blind phase, this represents approximately 13 per cent of the 593 patients (26 per cent of 49 per cent is 13 per cent). Since the number of patients studied is large, the confidence intervals are narrow, suggesting that this course characterizes a minimum of 10 per cent of all patients.

Is this applicable to a clinical setting where placebo prescription is not possible? On occasion, some patients note that the onset of improvement coincides with the decision to seek treatment and others note an improvement after speaking to a caregiver the first time. In the study described, 50 per cent of the minimally improved group had little risk of returning to their previous level of psychopathology. A reasonable strategy in a clinical setting might be to follow patients demonstrating early minimal improvement until they have two unimproved weeks, since two symptomatic weeks separated those with a good and poor prognosis. This clinical decision would take into account a variety of issues including the severity of past episodes, suicide risk, and relative contraindication to drug prescription. Although risk associated with newer antidepressants are small, side-effects do occur. It could be argued that this improvement is dependent on a pill placebo; however, some studies suggest that the mere attention of a caregiver accomplishes the same effect (no pill group) as a pill placebo. (3 35) Whether this strategy would reduce morbidity and cost for some patients is open to question. Obviously, studies with prolonged follow-up would help clarify this. In addition, this post hoc observation would have greater validity if replicated.

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