{"id":58259,"date":"2015-07-05T09:24:39","date_gmt":"2015-07-05T13:24:39","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=58259"},"modified":"2015-07-05T11:24:40","modified_gmt":"2015-07-05T15:24:40","slug":"still-happening","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/07\/05\/still-happening\/","title":{"rendered":"still happening…"},"content":{"rendered":"\n

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[click image for the full version]<\/sup><\/p>\n

In the 2000 US Census, they asked people to describe their ancestry. The map showing the dominant answer by County had an interesting spot. Instead of some comment about a foreign lineage, they just wrote "American." It’s in yellow and we call it Appalachia for obvious reasons. Outside the cities, it’s a culturally distinct place, generally poor, and filled with independent people descended from the independent people who gravitated to these mountains from who-knows-where. I live there, and one thing you keep up with in this part of the world is "drugs." This has been the moonshiner territory since the Civil War, and it remains a center for drug use – both legit [better than a sudoku…<\/a>] and street drugs. If you practice medicine here, you definitely hear about drugs. But that’s just a little epidemiological side trip. Here’s the main storyline.<\/div>\n

Some time back, I began to hear a new term – "New Vigil." I thought it was a street drug – slang – because the people where I live were traveling some 50 miles away during the recession to work in the numerous chicken processing plants there [shift work]. So I thought "New Vigil" was a nickname for some new version pep pill they were taking to stay up all night plucking chickens.<\/p>\n

That was sort of right, in spirit, but it was the prescription medication – Nuvigil<\/a>® they were seeking. It’s advertised for excessive daytime sleepiness, but was being used for excessive nightime sleepiness on the graveyard shifts at the chicken plants – much in demand. The manufacturer, Teva, has cast a wide net looking for other indications [see clinicaltrials.gov<\/a>]. Here’s one of their studies in Bipolar Depression: <\/div>\n
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Adjunctive armodafinil for major depressive episodes associated with bipolar I disorder.<\/a><\/div>\n
by Ketter TA, Yang R, and Frye MA.<\/div>\n
Journal of Affective Disorders<\/font><\/strong>. 2015 181:87-91.<\/div>\n

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BACKGROUND<\/font><\/strong><\/u>: In a previous study, adjunctive armodafinil 150mg\/day significantly improved depressive symptoms associated with bipolar I disorder.<\/div>\n
METHODS<\/font><\/strong><\/u>: Multicenter, double-blind study of patients with a major depressive episode despite bipolar I disorder maintenance therapy randomized to adjunctive placebo or adjunctive armodafinil 150 or 200mg\/day for 8 weeks; for logistical reasons, assignment to armodafinil 200mg\/day was discontinued early. Primary efficacy was measured by change from baseline to week 8 in 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) total score.<\/div>\n
RESULTS<\/font><\/strong>: Patients were randomized to adjunctive placebo (n=230), adjunctive armodafinil 150mg\/day (n=232), or adjunctive armodafinil 200mg\/day (n=30; analyzed for safety only). Least-square mean change in IDS-C30 total score was numerically superior for adjunctive armodafinil 150mg\/day vs adjunctive placebo, but was not statistically significant (p=0.13). Armodafinil was well-tolerated. Adverse events (AEs) observed in >5% with adjunctive armodafinil 150mg\/day and more frequently than with adjunctive placebo were headache (16% [38\/231] vs 13% [30\/229]) and nausea (7% [17\/231] vs 2% [5\/229]). The most common AEs with adjunctive armodafinil 200mg\/day were diarrhea and dry mouth (17% [5\/30] each vs 6% [13\/229] and 1% [3\/229], respectively, with adjunctive placebo).<\/div>\n
LIMITATIONS<\/font><\/strong><\/u>: Early study discontinuation for logistical reasons by the sponsor limited adjunctive armodafinil 200-mg\/day assessment.<\/div>\n
CONCLUSIONS<\/font><\/strong><\/u>: FDA-approved bipolar I depression treatments are limited. Adjunctive armodafinil 150mg\/day reduced depressive symptoms associated with bipolar I disorder to a greater extent than adjunctive placebo, although the difference failed to reach statistical significance.<\/font><\/strong><\/em> Safety data indicate treatment with adjunctive armodafinil was well-tolerated.<\/div>\n<\/blockquote>\n
If you actually read that abstract, you already know it was a very fishy write-up [in fact, it was outrageous]. Neuroskeptic spells it out for us: <\/div>\n
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Pharma Make The Most of A Negative Result<\/a><\/div>\n
Discover Magazine Blogs<\/font><\/strong><\/div>\n
By Neuroskeptic<\/div>\n
June 28, 2015<\/div>\n

A misleading piece of statistical rhetoric has appeared in a paper about an experimental antidepressant treatment. The study is published in the Journal of Affective Disorders<\/em><\/strong><\/a>. JAD<\/em> is a respectable mid-ranked psychiatry journal – yet on this occasion they seem to have dropped the ball badly. The study examined whether the drug armodafinil [Nuvigil] improved mood in people with bipolar disorder who were in a depressive episode. In a double-blind trial, 462 patients were randomized to treatment with either armodafinil 150 mg\/day, or placebo, in addition to their regular medication, for 8 weeks.<\/p>\n

The results showed no statistically significant difference between the two groups in change on the depression rating scale, the IDS-C30. [p = 0.24 LOCF, p = 0.13 at week 8]. So this means that there was no evidence that armodafinil helped treat depression. Oh dear. It’s a textbook example of a negative, or null, result. Despite this, however, the paper’s abstract concludes on a remarkably upbeat note…<\/div>\n