Today, the U.S. Food and Drug Administration (FDA) approved Symbyax for the acute treatment of treatment-resistant depression (TRD). It is the first drug approved for this indication. Symbyax is a combination pill that combines olanzapine (Zyprexa) and fluoxetine HCl (a long-acting form of …
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The amount of weight I gained when on Zyprexa will keep me far away from this new med. I have been through countless combination of medications combining both antipsychotics with high number of antidepressants and none of which last over time.
I HAVE HAD DEPRESSION FOR SO LONG, NOT JUST YEARS BUT DECADES. RECENTLY I STARTED GAINING WEIGHT FOR NO REASON. I EAT HEALTHY I’M 55 AND ALSO DIABETIC. I TAKE BYPOLAR MEDS. NOW THEY GIVE ME GENERIC, COULD THIS BE WHY I HAVE A SUDDEN CHANGE IN MY WEIGH? I DON’T WANT TO TRY ANY MORE DRUGS THAT MAKE ME GAIN. COULD YOU LEAVE ME A COMMENT ON THIS.
Hi, John and readers–
Thanks for this piece, John. I must say, I was a bit surprised by the FDA’s approval of this new combination treatment for “resistant depression”. I, too, have yet to review the raw data submitted to the FDA by the company; and, I have no reason to doubt that the studies done meet the usual FDA threshold, which means that the active medication must significantly out-perform a placebo (sugar pill). But that is a fairly easy bar to jump over. In fact, back when I was seeing patients in my psychopharmacology consultation practice, I had a term for patients “who have not responded to two separate trials of different antidepressants of adequate dose and duration”–I called them “The easy ones”!
Most of the patients sent to me–usually by other psychiatrists–had “failed” four, five, six, or sometimes 10 or more courses of treatment. Often, these treatment regimens were inappropriately prescribed to patients who had undiagnosed bipolar spectrum disorder–the supposed “failure” was really a poor response to antidepressants, usually involving agitation, insomnia, and irritability. In any case, the notion that someone who has not responded to two adequate courses of antidepressant treatment has “treatment-resistant depression” (TRD)is a bit on the liberal side for me. I am not opposed to offering folks with TRD this new combination [Symbyax], but there are alternative augmentation strategies that may have fewer side effects for many patients who have not responded to single-agent, sequential treatment (sometimes called “sequential monotherapy”). For example, a partial response to an SSRI (such as Prozac, Zoloft, Paxil, etc.) may be augmented by adding a small amount of bupropion (Wellbutrin and others), thyroid hormone, or lithium. The last two (thyroid or lithium augmentation) have a reasonably good “evidence base”, though it is far from perfect. For many (though not all) patients, these strategies may have fewer side effects than a combination of olanzapine [Zyprexa] and fluoxetine [Prozac], the two ingredients in Symbyax. The olanzapine component of Symbyax is particularly concerning, since it is known to promote weight gain, glucose intolerance, and unhealthy changes in blood lipids (fats) in a high percentage of cases.
Of course, all this talk of pharmacotherapy should not distract us from noting the importance of “adding psychotherapy” to ongoing antidepressant medication. In many cases–often involving primary care physicians, who often are not in a position to provide psychotherapy–a patient has been treated with two antidepressants, but has never been involved in ongoing psychotherapy. This is a reflection of the fragmented and often inaccessible mental health care system in the U.S. Patients should not be given a “set and forget” approach to their depression (i.e. a medication alone) and then be sent on their way!
In short–and pending my review of the FDA data–I have some reservations about jumping in too quickly with Symbyax for “TRD”, though it may be entirely appropriate for carefully-selected patients with TRD. Those who care to read more detailed information on the treatment of depression can find a good, recent update by Bhalla et al, at:
http://emedicine.medscape.com/article/286759-treatment
–Best regards, Ron Pies MD
Ronald Pies MD is Professor of Psychiatry at SUNY Upstate Medical University, Syracuse, NY; and Clinical Professor of Psychiatry, Tufts USM, Boston. He is Editor-in-Chief of Psychiatric Times. A disclosure statement for Dr. Pies is posted on line at the Psychiatric Times website. He reports no conflicts of interest with respect to the above material.
I have been on literally dozens of drugs and combinations over the years without much success. My primary diagnosis is Bipolar Disorder.
I have also spent many years in psychcotherapy as well.
I feel pretty much hopeless that I will ever feel much sense of relief from my TRD.
I am truly ready to give up.
My very recent discovery of TRD as a concept gives me hope for my daughter who has a 17 year history of depression, has had multiple courses of drugs and is in psychotherapy. Half her life has been destroyed by this disease and so has 2/3ds of mine. There might be a scintilla of light on the horizon for both of us though the way to treatment will undoubtedly be stoney and filled with obstacles.
Antipsychotic uses is not the only avenue of treatment we need to explore. I’m one of those people who cannot touch antipsychotics due to severe extrapyramidal reactions. TRD is a tough condition to live with.