Zoloft And Therapy Reduced Anxiety In Kids: Study
14 CommentsBy Ed Silverman // October 30th, 2008 // 5:39 pm
Using a combination of cognitive behavioral therapy and Pfizer’s antidepressant dramatically reduced the severity of anxiety disorders in children compared with either treatment alone, according to a study in The New England Journal of Medicine.
The findings are likely to add to the ongoing controversy about giving antidepressants to children. In 2004, the FDA required drugmakers to add Black Box warnings to antidepressants concerning suicide and suicidal thoughts in children. That led to yet another controversy that some doctors stopped prescribing the meds as often, leading to a rise in teen suicides (back story).
In the study, which was funded by the National Institutes of Mental Health and involved 488 kids between ages 7 and 17, none of the children committed suicide, and there was no significant increase in suicidal thoughts among those taking Zoloft (here is the study).
Some kids also underwent cognitive behavioral therapy, or CBT, which is not the same as traditional psychotherapy. Instead, CBT is usually for a shorter length of time and tries to help a patient develop strategies to obliterate negative thoughts. In the study, patients received 14 sessions of CBT that each lasted an hour. Of patients receiving Zoloft and CBT, 81 percent showed improvement, compared to 60 percent for CBT alone, 55 percent on Zoloft, and 24 percent on a placebo.
Jeff Wilson
No surprises here. When you pay fir the study you get to determine the results. For the truth about antidepressants check out http://www.depressionhope.net
laurie
A 12 week study with 8 weeks of therapy. Increased subject withdrawal from the zoloft group compared to the therapy group, no blinding of the zoloft group….and the most significant result, which was dismissed in this study was :
“Of the 14 withdrawals that were attributed to an adverse event, 11 (78.6%) were in the groups receiving either sertraline alone or placebo and consisted of 3 physical events (headache, stomach pains, and tremor) and 8 psychiatric adverse events (worsening of symptoms, 3 subjects; agitation or disinhibition, 3; hyperactivity, 1; and nonsuicidal self-harm and homicidal ideation, 1). ”
And below the dismissal of “worsening behavior”, which is what the black box warning is all about, is also dismissed.
“Three subjects had serious adverse events during the study period. One child in the sertraline group had a worsening of behavior that was attributed to the parents’ increased limit setting on avoidance behavior; the event was considered to be possibly related to sertraline. A child in the combination-therapy group had a worsening of preexisting oppositional–defiant behavior that resulted in psychiatric hospitalization; this event was considered to be unrelated to a study treatment”
Lisa Van S
Couple of questions!… Who were the clinical trial investigators, (Karen Wagner) or others who have previously worked for Industry. MONEY?.. Wow, this Study reminds me of the infamous Paxil 329 study.
Lisa Van S
Ed,
Did you fall asleep on this one? No Increase in Suicidal Thoughts, Homicidal thoughts occured! How troubling is that!!!
Lisa Van S
laurie,
Really looks like the Paxil 329 Study, would love to see the raw data!!!!!!!!!!!!!
Sam
I too would like to see the raw data. “… dramatically reduced the severity of anxiety disorders …” does not necessarily mean improvement.
Does “dramatically reduced” mean that the child became happier, or was the child’s emotional tone depressed further by the drug so that they went below anxiety into uncaring apathy?
“How do you feel about {whatever the child was anxious about} now?”
could be answered with:
“Better”
or
“About the same”
or
(apathetic/hopeless) “Who cares?”
AA
To add to the great comments already posted, 3 month isn’t really long enough to decided if CBT by itself is more effective or just as effective as the combined treatment. As this study on Furious Seasons shows regarding CBT and Prozac for the study of depression, the longer CBT goes in comparison to the combined treatment, it turns out to be just as nearly effective. Short term, like the study on CBT and Zoloft for anxiety, the results are similar for all the treatments.
http://tinyurl.com/yowcj5
AA
Andy
thank you tom cruise
Doug Bremner
WSJ quoted a doctor as saying the results of this study were “incredible”. However if you compare this one to Study 329, effects of paroxetine on depression in children, the results are not that different. In the case of Study 329, 66% of kids treated with Paxil (paroxetine) were “much improved” or better as measured by the Clinical Global Impression Scale (CGI) [criteria used in the sertraline/Zoloft study] versus 48% of those treated with placebo, which they reported as statistically significant. However they did not find a significant change in their primary outcome [change in Hamilton Depression Scale score], and to report the study as positive is a violation of the rules of clinical trials, as pointed out in a subsequent letter to the editor. In fact, if you look at the actual data, the Ham D score went from a baseline of 19.0 in both groups, to 8.2 in the paroxetine group and 9.9 in the placebo group, only a 3% difference in a 56 point scale which was not significantly different. Compare that to the study of sertraline (Zoloft) in kids. Although there was a difference in “responders” based on much improved on the CGI of 60% versus 24% for placebo, when you look at the actual data, the Pediatric Anxiety Scale, a 30 point scale, went from 18.8 at baseline to 9.8 in the zoloft group, and from 19.6 to 12.6 in the placebo group, a difference of 9%, again, not reported as statistically significant.
Doug Bremner
Also the primary outcome of “much improved” on the CGI is misleading. let me give an example. Say the primary goal is to run a mile in 10 minutes (or whatever, I say as I sit in my office chair). If out of 100 people running, people wearing green shirts do it, on average, in 9 minutes 45 seconds, and people wearing red shirts do it in 10 minutes 15 seconds, you could have a result where 60% of the green shirts make the goal versus 25% of the red shirts, which sounds like a big deal, even though there is only a 5% difference in their times.
Similarly, there is only a 9% difference between placebo and zoloft, and when I went back to look at the results, there was not a significant difference between placebo-zoloft or placebo-combination, only placebo-therapy for the anxiety scale! [no time-treatment interaction] They only had one doubtful comparison of scores at the end of treatment. Incredible results indeed.
Lisa Van S
Paxil Study 329 was described as “remarkable”. And now the Zoloft is deemed “Incredible”. Reminds me of how Pfizer a few years back combined two negative studies to get one positive!!! And they’d like us to trust their math. I am sure the raw data would paint a much different picture.
Lisa Van S
One last comment, Candace Downing, at age 12 was prescribed Zoloft for test anxiety. She hung herself from her canopy bed. Parents must heed the Black Box Warnings. Candace and her family payed the ultimate price.
truthman30
Does anyone here trust the conclusions of this study? ..
If so , perhaps they should consider the following information sourced from the original article before they decide ..
http://content.nejm.org/cgi/content/full/NEJMoa0804633
Supported by grants (U01 MH064089, to Dr. Walkup; U01 MH64092, to Dr. Albano; U01 MH64003, to Dr. Birmaher; U01 MH63747, to Dr. Kendall; U01 MH64107, to Dr. March; U01 MH64088, to Dr. Piacentini; and U01 MH064003, to Dr. Compton) from the National Institute of Mental Health (NIMH). Sertraline and matching placebo were supplied free of charge by Pfizer.
Dr. Walkup reports receiving consulting fees from Eli Lilly and Jazz Pharmaceuticals and fees for legal consultation to defense counsel and submission of written reports in litigation involving GlaxoSmithKline, receiving lecture fees from CMP Media, Medical Education Reviews, McMahon Group, and DiMedix, and receiving support in the form of free medication and matching placebo from Eli Lilly and free medication from Abbott for clinical trials funded by the NIMH; Dr. Albano, receiving royalties from Oxford University Press for the Anxiety Disorders Interview Schedule for DSM-IV, Child and Parent Versions, but not for interviews used in this study, and royalties from the Guilford Press; Dr. Piacentini, receiving royalties from Oxford University Press for treatment manuals on childhood obsessive–compulsive disorder and tic disorders and from the Guilford Press and APA Books for other books on child mental health and receiving lecture fees from Janssen-Cilag; Dr. Birmaher, receiving consulting fees from Jazz Pharmaceuticals, Solvay Pharmaceuticals, and Abcomm, lecture fees from Solvay, and royalties from Random House for a book on children with bipolar disorder; Dr. Rynn, receiving grant support from Neuropharm, Boehringer Ingelheim Pharmaceuticals, and Wyeth Pharmaceuticals, consulting fees from Wyeth, and royalties from APPI for a book chapter on pediatric anxiety disorders; Dr. McCracken, receiving consulting fees from Sanofi-Aventis and Wyeth, lecture fees from Shire and UCB, and grant support from Aspect, Johnson & Johnson, Bristol-Myers Squibb, and Eli Lilly; Dr. Waslick, receiving grant support from Baystate Health, Somerset Pharmaceuticals, and GlaxoSmithKline; Dr. Iyengar, receiving consulting fees from Westinghouse for statistical consultation; Dr. March, receiving study medications from Eli Lilly for an NIMH-funded clinical trial and receiving royalties from Pearson for being the author of the Multidimensional Anxiety Scale for Children, receiving consulting fees from Eli Lilly, Pfizer, Wyeth, and GlaxoSmithKline, having an equity interest in MedAvante, and serving on an advisory board for AstraZeneca and Johnson & Johnson; and Dr. Kendall, receiving royalties from Workbook Publishing for anxiety-treatment materials. No other potential conflict of interest relevant to this article was reported.
The views expressed in this article are those of the authors and do not necessarily represent the official views of the NIMH, the National Institutes of Health, or the Department of Health and Human Services.
We thank the children and their families who made this study possible; and J. Chisar, J. Fried, R. Klein, E. Menvielle, S. Olin, J. Severe, D. Almirall, and members of NIMH’s data and safety monitoring board.
* The study investigators are listed in the Appendix.
http://content.nejm.org/cgi/content/full/NEJMoa0804633
Lisa Van S
Dr March was a defennse expert for Solvay Pharmaceuticals in Taylor vs Solvay (Columbine). He is also the author of the TADS Study. Dr. Mosholder, under oath, testified before Congress, that the TADS Study didnt meet FDA Standards for approval.