Posted by pharmrep on September 7, 2002, at 0:01:22
In reply to Re: Serious question for pharmrep, posted by ZyprexaNumbTongue on September 6, 2002, at 15:12:38
> Hi Pharmrep, I would like to know about the types of depressives who took part in these Lexapro clinical trials.
>
> 1) How many of them had severe depression, the type generally referred to as the "melancholia subtype" of depression? This type of depression is also known as endogenous depression and consists of severe deteriorations in sleeping cycles especially severe insomnia, losing weight and appetite without trying, losing sex drive and losing sexual functioning, losing normal cognition such as inability to concentrate, remember, decide, think clearly, etc. Also, melancholic depressives tend to lose their sense of taste and smell. Did Lexapro restore sense of smell and taste?
>
> 2) How many of the depressives in the Lexapro trials were recruited and had milder to moderate forms of depression known as "dysthymia."
>
> 3) what were the full remission rates for Lexapro?
>
> 4) What were the full remission rates for the people who had the severe melancholic form of depression? Or did these people just get a "response" and improve some, but not get totally well?
>
> How many of these depressives in the Lexapro trials were considered disabled and unable to work? Did Lexapro restore their disability and make them undisabled and able to work?
>
> These are very important questions for you. I am not sure you will even know the answers to these questions, but Im asking anyway.
>
> thanks,
>
> ********* Wow, tough questions...here's what I can offer: In Gorman, all patients scored at least 22 on the MADRS which meets criteria for a major depressive episode. Candidates were excluded if there was evidence of active suicide ideation or attempt, or if they had any DSM-IV Axis I disorder other than major depression. Study had 1321 patients.
In Burke, same as Gorman and No concomitant psychotropic medication was permitted, except zolpidem for insomnia. (491 patients )
In Wade, same as Gorman, except patients were also excluded if met criteria for mania, or any bipolar disorder, schizophrenia or any psychotic disorder, ocd, eating disorders, mental retardations, any pervasive developmental disorder or cognitive disorder. Not allowed were any antipsychotics, antidepressants, hypnotics, anxiolytics, antiepileptics, barbiturates, chloralhydrate or other 5HT receptor agonists or ec treatment or behaviour therapy. (380 patients)
Other studies are out, but I only have posters which are limited on info...If I get full blown study...I will update.
As for remission rates...Need to get the specifics in the Rappaport study....it was just approved for the indication (maintenance therapy..based on achieved remission) last week from FDA. All I know is it was a good result as far as 6 months post med and not having relapse. (actual remission #'s vary...I just know it was a good "response" and another "positive" study. As for disabled...dont know anything about that.
"WHEW" that was a lot of typing...hope that helps.
poster:pharmrep
thread:109458
URL: http://www.dr-bob.org/babble/20020906/msgs/119141.html