Failed antidepressant trials

Try out PMC Labs and tell us what you think. Learn More. Each step consisted of a week, open-label trial, with an additional 2 weeks for patients deemed close to remission. CT was also available as a switch or drug augmentation option in step 2, but too few patients included it as an acceptable treatment, resulting in only contributing data after randomization.

Therefore, CT was excluded from the step 2 switch and augmentation analyses. Patients who achieved remission during any step were encouraged to enter the 12 months of free follow-up care, as were responder patients who failed to attain remission but did not want to continue to the next treatment step as this would involve a change in medication.

Pigott and colleagues 7 , 8 have previously criticized the investigators for the following:. Further, no post hoc secondary analyses have reported significant predictors of outcomes between the pharmacologically distinct treatments. This approach seems more realistic than the summary article 5 that used as the denominator, thereby excluding from analysis the early dropout patients who did not return for subsequent treatment visits.

Comparison between predicted, theoretical, and actual step-by-step success rates. For each step, subtract the per cent relapse rate from 1. Repeat for steps 2 to 4. Add the remitted patients without confirmed relpase for steps 1 to 4 and divide by This assessment was administered at each clinic visit and monthly by telephone during follow-up. By step 4, the cumulative per cent of such patients who entered follow-up was only While both calculations used as the denominator, these findings improve little when using patients as the denominator For step 1, only After up to 4 rounds of AD drug—drug combination treatments, the cumulative rate of patients who did not have a confirmed relapse improved to only When drop out is added, the durability of treatment effects is even paltrier.

Only 2. It demonstrates how each change in treatment resulted in an increased rate of intolerable side effects from the newly prescribed medication, compared with the prior step, increasing from This same trend is seen for study drop out, with it increasing from Both measures demonstrate an increasing risk to patient care tied to each change in AD drug—drug combination treatment as patients progressed from step 1 through steps 2 to 4.

Results: Funding source differentiated medication-placebo differences regardless of disorder. Industry trials had larger placebo response rates mean difference: 0. However, medication response was similar for industry- and federally-funded studies But hidden in this demoralizing research are two surprising pieces of good news. The first is a reminder of a law passed in in the U. That law is protecting American consumers. So, props to Congress and the FDA on that one. More on Time.