May 07, 2008

Lexapro For Teens!!!

The fine folks at Forest Labs today rolled out results from a clinical trial of teens diagnosed with major depression, while carefully noting that the drug is not approved for use in treating depression in teens. Let the off label marketing begin!

"A double-blind, parallel-group, placebo-controlled phase III study to evaluate the safety and efficacy of Lexapro in the treatment of depressed adolescents, aged 12-17, was conducted in multiple centers across the U.S. A total of 316 patients entered the eight week study, receiving either Lexapro 10-20 mg (n=158) or placebo (n=158). The primary endpoint was change from baseline to Week 8 on the Children's Depression Rating Scale - Revised (CDRS-R) using last observation carried forward (LOCF) approach. The CDRS-R is a commonly used clinician-rated instrument that covers 17 symptom areas of depression relevant to adolescents, including impaired schoolwork, difficulty having fun, social withdrawal, physical complaints, and low self-esteem. The study showed statistically significant improvement in patients treated with Lexapro relative to placebo based on the change from baseline in the CDRS-R score (-22.1 for Lexapro vs. -18.8 for placebo treatment; p=0.022)."

The improvement in the CDRS-R scores is an average of all the patients in a particular arm of the study, so it's not clear what percentage of patients in the Lexapro arm of the study received whatever benefit might be ascribed to Lexapro. I'll have to wait for the published results to be able to dig up those bones.

Until then, I'd say teens and their parents ought to be damn careful when using any anti-depressant--that black box warning isn't on Lexapro and the other anti-depressants for nothing, regardless of what Fred Goodwin thinks. To be fair, Lexapro is a long way from Paxil and Effexor on the ugly meter, but it's still an SSRI and the Brits banned all SSRIs (except for Prozac) for use in under-18s.

Posted by Philip Dawdy at May 7, 2008 12:34 PM
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Comments

Once again it's that red flag of an 8 week response that people have got to watch out for; and it's really unbelievable they keep trialing these meds for use in kids. Age 12? No way they can say what happens to that child's brain on this stuff. Isn't this the drug that is Celexa's twin? similar? I was offered Lexapro instead of a Lamictal increase for depression and I declined and yet was given Lamictal samples in a Lexapro gift bag dropped off by drug reps. It's just a sick industry going for sales vs. safety of children and adults with regard to SSRIs and others.

Posted by: Stephany at May 7, 2008 02:06 PM

A 2.3 point difference on the CDRS is nothing to get excited about. I'd have to see the study in full to run the numbers, but it's pretty clear just from the press release that we're talking a small benefit over placebo. Just another page from the same, tired, script.

Posted by: CL Psych at May 7, 2008 03:02 PM

Also, no mention of side effects, including jitters and weight gain. As we all know, jitters may lead some to decide the kids actually have bipolar, and weight gain - particularly in adolescents - can lead to diabetes.

Posted by: Anne at May 13, 2008 11:22 AM

Emergence of Electric Shock-like Sensations on Escitalopram Discontinuation (brain zaps coming off/withdrawals/tapering of Lexapro).

Is acknowledged in a Journal article from June, where (Dr.) Dawdy's letter was answered by Dr. Thase.

I think it's time brain zaps got the attention they deserve, because removing these drugs can be a living nightmare people need to know about before beginning them, especially teens!

Posted by: Stephany at May 15, 2008 10:09 AM

I just got done looking over the May 28 JAMA article (Robinson et al) on escitalopram (AKA Lexapro), versus problem-solving therapy (and placebo) for preventing depression post-stroke.
[Dep is fairly common in the couple yrs post-stroke and post-MI.]
PST did OK, Lexapro did better, and both did better than placebo. Good. But digging into the artlce yileds an interesting finding. The article itself is long on details of what PST is and how 'supervised,' but skimpy on the actual execution of the therapy. A note following the article gives thanks to two people for providing PST therapy. One has bachelor's degree, and one has master's degree. I did a little web search: the master's level person comes up as a reserch assistant who has worked in this psychiatry resaerch group, including co-author on several med studies. However, a quick search did not yiled evidence of licensure in mental health counselign in the home state (Iowa) of the study and this master's level provider of PST.

Thus, possibly, the way that the study design was able to show Lexapro as superior to therapy was by having the therapists be people who were not actually counselors or therapists (take your preference of terminology). I am sure they are fine people. But does it make sense to compare meds to therapy in a head-to-head trial, and use people who are not licensed therapists? In a psychiatry department?

Curious. So, I looked up the study in CRISP (a federally operated data base of federally funded research; easy to use). The study (R01 MH65134) proposal abstract notes that the study will compare escitalopram, nortryptyline, and PST. And placebo. Well, what happened to the nortryptyline AKA Pamelor (no longer under patent)? Did it come out the best of all?

Posted by: Row1 at July 2, 2008 02:19 PM

Row1: very interesting information in your comment, thanks.

Posted by: Stephany at July 2, 2008 06:15 PM
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