![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 6 of 6. This is the beginning of the thread.
Posted by OldSchool on April 2, 2002, at 0:54:55
It was recently announced that the much hyped "MAOI Patch" that uses selegiline was rejected by the FDA. In fact this was announced this past week. I feel this MAOI patch is a good idea as there are many TRDepressives who could greatly benefit from an MAOI. But are intimidated by the MAOI diet and the ever present risk of an MAOI hypertensive crisis. The patch is supposed to get rid of a lot of these sorts of problems, eliminate the MAOI diet basically.
Frankly, I am disgusted this novel drug was rejected by the FDA.
Do you have any specific knowledge of the reason(s) why this MAOI patch was not FDA approved?
Old School
Posted by Dr. Kramer on April 2, 2002, at 12:03:54
In reply to Kramer: reason the MAOI patch was rejected?, posted by OldSchool on April 2, 2002, at 0:54:55
> It was recently announced that the much hyped "MAOI Patch" that uses selegiline was rejected by the FDA. In fact this was announced this past week. I feel this MAOI patch is a good idea as there are many TRDepressives who could greatly benefit from an MAOI. But are intimidated by the MAOI diet and the ever present risk of an MAOI hypertensive crisis. The patch is supposed to get rid of a lot of these sorts of problems, eliminate the MAOI diet basically.
>
> Frankly, I am disgusted this novel drug was rejected by the FDA.
>
> Do you have any specific knowledge of the reason(s) why this MAOI patch was not FDA approved?
>
> Old SchoolYeah. Unfortunately, it didn't work all that well. A Phase III clinical trial completed a while ago showed no signifigant difference from placebo.
Posted by Tye on April 2, 2002, at 20:20:07
In reply to Re: Kramer: reason the MAOI patch was rejected?, posted by Dr. Kramer on April 2, 2002, at 12:03:54
> Yeah. Unfortunately, it didn't work all that well. A Phase III clinical trial completed a while ago showed no signifigant difference from placebo.
Dear Dr. Kramer,
Actually the rate of response of the subjects enrolled in the selegiline patch study was approximately 75%. This was amongst a population that was for the most part treatment resistant with HAM-D scores averaging around 30. Unforunately, political agendas impair excellent medications from reaching the United States patient population, as I am sure your aware.
Tye
Posted by OldSchool on April 2, 2002, at 20:52:22
In reply to That is incorrect Dr. Kramer, posted by Tye on April 2, 2002, at 20:20:07
> > Yeah. Unfortunately, it didn't work all that well. A Phase III clinical trial completed a while ago showed no signifigant difference from placebo.
>
> Dear Dr. Kramer,
>
> Actually the rate of response of the subjects enrolled in the selegiline patch study was approximately 75%. This was amongst a population that was for the most part treatment resistant with HAM-D scores averaging around 30. Unforunately, political agendas impair excellent medications from reaching the United States patient population, as I am sure your aware.
>
> TyeThis was my impression of high dose selegiline. Its an excellent...outstanding antidepressant at doses of 30 mg and above. In fact, there is a whole string about high dose selegiline used as a regular MAOI for depression in the tips and tricks on this website. Many of the Pdocs who posted in the tips here who have used selegiline at higher irreversible MAOI dosages say its a fine AD.
Something isnt right here. Either this MAOI patch doesnt use a high enough dose of selegiline. Or it fails in the delivery somehow. But I am skeptical that high dose selegiline is as good as "placebo" for severe depression.
I agree about the political agendas as well. There isnt enough good research in psychiatry. Mostly its just "another SSRI" type research. Or psychobabble crap.
Old School
Posted by OldSchool on April 2, 2002, at 20:58:44
In reply to Re: Kramer: reason the MAOI patch was rejected?, posted by Dr. Kramer on April 2, 2002, at 12:03:54
>
> Yeah. Unfortunately, it didn't work all that well. A Phase III clinical trial completed a while ago showed no signifigant difference from placebo.
Dr. Kramer, the following was copied and pasted directly from this website:Selegiline for depression
--------------------------------------------------------------------------------
Date: Sun, 05 Jan 1997 23:01:02 -0500
From: Ivan Goldberg <Psydoc@psycom.net>
Subject: Selegiline for depressionSelegiline is a partially selective (MAO-B) inhibitor. At the doses prescribed for the treatment of Parkinson's disease, up to 10 mg/day, there is no need for the patient to avoid tyramine-containing foods.
When 40 mg/day is prescribed in divided doses, there is inhibition of both MAO-A and MAO-B, and an antidepressant effect is often noted. At such doses a tyramine-restricted diet is necessary. I have used selegiline, sometimes with excellent results, as an antidepressant in people who had originally been started on it, in lower doses, for Parkinson's disease.
--------------------------------------------------------------------------------
From: dreise02@interserv.com (David Reiser, M.D.)
Date: Wed, 8 Jan 1997 20:12:43 -0800
Subject: Selegiline for depressionSelegiline is a good antidepressant. Doses use to treat depression, unlike those for Parkinsons's disease, are in the 40 to 60 mg per day range. I give selegiline to my depressed patients all the time, usually in the 15 to 30 mg bid range. I start at no more than 5 mg bid and work up slowly. What you must be sure to tell your patient is that at these higher doses selegiline becomes non-selective and can produce a full blown MAOI food reaction, just as any MAOI can. Hence, your patient will need to be educated about food restrictions, drug restrictions, and the use of sublingual nifedipine in an emergency. MAOI rises at these higher doses of selegiline can and do occur.
--------------------------------------------------------------------------------
From: dreise02@interserv.com (David E. Reiser, M.D.)
Date: Fri, 10 Jan 1997 13:57:33 -0800
Subject: Selegiline for depressionExpense is not one of selegiline's selling points, nor are those curious little glances you get from pharmacists. Nevertheless, selegiline does have certain advantages, useful for some patients.
First, it autometabolizes in small amounts to amphetamine and methamphetamine. This can provide the patient with some relief from the intrinsic sedation of MAOIs. It is somewhat unpredictable, however, and depends on the patient. I had one patient who dragged around all day, only to wake bolt upright a 3 AM. This wasn't early morning awakening due to depression; this was being caused by endogenously produced peaks of methamphetamine arriving at a time of day that did him little good.
Selegiline's second advantage is the built-in pressor effect of the amphetamines, which counteracts the often quite serious hypotension that all the MAOIs produce. So, I don't think it's always frivolous, or simply giving a more expensive drug than indicated, to consider selegiline.
--------------------------------------------------------------------------------
Date: Thu, 10 Apr 1997 17:13:03 -0700 (PDT)
From: "J. Wynn" <jdwynn@u.washington.edu>
Subject: Selegiline for depressionIn my series of less than 100 patients (two so far) I have had some very nice responses to selegeline/deprenyl after failing multiple medication trials including multiple augmentation strategies.
You can tell that it isn't yet one of the first things that I try, but so far, so good.
--------------------------------------------------------------------------------
Date: Thu, 10 Apr 1997 20:23:03 -0400
From: Ivan Goldberg <Psydoc@PsyCom.Net>
Subject: Selegiline for depressionMy series is less than a hundred, too. When prescribed in doses around 40 mg/day, I find that selegiline is a fair antidepressant, equivalent maybe to 30 mg of phenelzine. When prescribed in low doses, 10 or less mg/day, it seems to have just about no antidepressant activity... at least in the super-depressed people I get to see.
--------------------------------------------------------------------------------
Date: Sat, 14 Jun 1997 22:24:00 -0700 (PDT)
From: "J. Wynn" <jdwynn@u.washington.edu>
Subject: Selegiline for depressionOne of them -- a bipolar patient -- finds that the antidepressant effect wears off by mid-afternoon (I don't think he is rapid cycling).
At 10 mg/day, a one month supply costs $140 in Seattle. The manufacturer (Somerset) has no patient assistance program but they will send you samples if you contact them directly.
--------------------------------------------------------------------------------
From: "Randall Riggs" <riggs@workmind.com>
Subject: Selegiline for depression
Date: Sun, 15 Jun 1997 23:03:24 -0700I am reporting similar encouraging results in two cases.
The first patient is a severely depressed elderly man who had incomplete responses to a wide variety of antidepressants and stimulants. He probably did the best on 70-80 mg of tranylcypromine, but got scared of some side effects (momentary blackouts). He does as well on 10 mg of selegiline with precursor loading, with fewer side effects. It has not been helpful with his sleep disturbance, and it is still an incomplete response.
The second patient is a dysthymic-to-depressed 40-ish man who reports feeling "generally a lot better" on 10 mg per day. His mood and energy increased significantly. Precursor loading (1500 mg of d-l-phenylalanine in the am) made him feel too pressured. He has no sleep disturbance. He subsequently requested decrease of the dose to 5 mg per day and is doing well on that. I don't think he is bipolar.
Neither patient shows the diurnal variation of antidepressant effect reported by Dr. Wynn. (I wonder if this could be the effect of the conversion of selegiline to amphetamine in the CNS -- or of cessation thereof. It doesn't seem likely that it is from lower levels of selegiline, since this is an irreversable MAOI.)
If you are in the United States, selegiline can be ordered from abroad at about half the local price (still expensive!). It is manufactured by the Italian pharmaceutical company Chiesi under the brand name "Jumex". I had heard reports earlier that one had to use dosages of 30 mg or more to get an antidepressant effect -- which would seem to offer no advantage over non-selective MAOIs.
--------------------------------------------------------------------------------
Date: Mon, 09 Feb 1998 09: 39: 50 -0500
From: Bonnie Szarek <Bszarek@harthosp.org>
Subject: Selegiline for depressionThere have been a number of articles on this, though most of them were published quite a few years ago.
Steur EN, Ballering LA: Moclobemide and selegeline in the treatment of depression in Parkinson's disease (letter). J Neurologhy, Neurosurgery & Psychiatry 1997; 63: 547.Sunderland T, et. al.: High-dose selegiline in treatment-resistant older depressive patients. Arch Gen Psychiatry 1994; 51: 607-15.
Mcgrath PJ et. al.: A placebo-controlled trial of L-deprenyl in atypical depression. Psychopharm Bull 1989; 25: 63-7.
Mann JJ, et. al.: A controlled study of the antidepressant efficacy and side effects of (-)-deprenyl, a selective monoamine oxidase inhibitor. Arch Gen Psychiatry 1989; 46: 45-50.
Quitkin FM, et. al.: l-deprenyl in atypical depressives. Arch Gen Psychiatry 1984; 41: 777-81.
Birkmayer W, et. al.: L-deprenyl plus L-phenylalanine in the treatment of depression. J Neural Transmission 1984; 59: 81-7.
Mendlewicz J, Youdim MBH: L-deprenil, a selective monoamine oxidase type B inhibitor, in the treatment of depression: a double blind evaluation. Br J Psychiatry 1983; 142: 508-511.
Mann JJ, et. al.: Differential efficacy of L-deprenyl, a selective MAO type-B inhibitor, in endogenous and nonendogenous depression. Psychopharm Bull 1982; 18: 182-4.
--------------------------------------------------------------------------------From: ConEmo@aol.com (Ron Podell)
Date: Mon, 9 Feb 1998 01:27:12 EST
Subject: Selegiline for depressionI have used eldepryl many times because it gives MAO inhibition with fewer side effects. The problem is that in order to get both MAO A and B inhibition you have to give 25 to 60 mg. Now that it is generic, the price is much more reasonable. If you try it, you may like it. Meanwhile, once you get past 15 mg, full MAOI warnings are indicated.
--------------------------------------------------------------------------------
From: Shalomf@aol.com (Shalom Feinberg MD)
Date: Wed, 30 Sep 1998 21:44:58 EDT
Subject: Selegiline for depressionMy experience with selegiline involves a couple of patients who couldn't tolerate Nardil (phenelzine). Using it in the 60 mg/d range, side effects seem a tad milder and clinically the response not quite as robust, but it is significantly more expensive!
Posted by Elizabeth on April 4, 2002, at 22:37:39
In reply to That is incorrect Dr. Kramer, posted by Tye on April 2, 2002, at 20:20:07
> Actually the rate of response of the subjects enrolled in the selegiline patch study was approximately 75%.
My recollection is that there were different sites. Was this the response rate at one of these sites, or the combined response at all the sites?
I think it's well established that selegiline is an effective antidepressant in the higher dose range. The only possible reason why the patch might not work would be that it didn't deliver the drug effectively.
The whole thing seems damned peculiar to me.
-elizabeth
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.