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Dr. Bob is Robert Hsiung, MD,
[email protected]Shown: posts 1 to 16 of 16. This is the beginning of the thread.
Posted by Phillipa on December 8, 2009, at 20:19:59
FDA just approved long acting seroquel for an add on for MDD. Phillipa
From Medscape Medical News > Alerts, Approvals and Safety Changes > FDA Approvals
FDA Approves Extended-Release Quetiapine as Add-On Treatment of Depression
Yael Waknine
December 7, 2009 The US Food and Drug Administration (FDA) has approved a new indication for quetiapine fumarate extended-release tablets (Seroquel XR, AstraZeneca Pharmaceuticals, LP), allowing their once-daily use as adjunctive treatment to antidepressants in adults with major depressive disorder (MDD). The recommended dose range is 150 to 300 mg/day."Many people with [MDD], despite being treated with currently approved medications, continue to experience depressive symptoms," said Richard Weisler, MD, adjunct professor of psychiatry at the University of North Carolina School of Medicine, Chapel Hill, and adjunct associate professor at Duke University Medical Center, Durham, North Carolina, in a company news release. "Seroquel XR may provide another effective treatment option for the depressive symptoms associated with MDD as adjunctive treatment to antidepressants."
The FDA's action was based on data from 2 phase 3 clinical studies of 939 patients with refractory MDD, showing that the addition of extended-release quetiapine to antidepressant therapy yielded significantly greater reductions in Montgomerey-Asberg Depression Rating Scale total score.
Adverse events most commonly reported in study patients receiving quetiapine were consistent with the drug's profile and included somnolence (150 mg/day, 37%; 300 mg/day, 43%), dry mouth (150 mg/day, 27%; 300 mg/day, 40%), fatigue (150 mg/day, 300 mg/day, 14%; 11%), and constipation (150 mg only, 11%).
Other potential adverse events related to use of the atypical antipsychotic may include rapid weight gain, tardive dyskinesia, suicidal thinking and behavior, neuroleptic malignant syndrome, hyperglycemia, increased cholesterol levels, leukopenia, neutropenia, and agranulocytosis.
Because of these and other risks, the FDA is requiring implementation of a risk evaluation and mitigation strategy for all quetiapine indications. The program requires a medication guide and periodic assessments that include a survey of patients' understanding regarding the potential adverse effects of treatment.
Quetiapine extended-release tablets previously were approved for the treatment of schizophrenia, depressive episodes of bipolar disorder, manic or mixed episodes of bipolar disorder as either monotherapy or adjunct therapy to lithium or divalproex, and the maintenance treatment of bipolar disorder as adjunct therapy to lithium or divalproex.
Other indications currently under FDA review include acute monotherapy and maintenance monotherapy for the treatment of MDD in adult patients.
Posted by RSidney on December 8, 2009, at 20:39:56
In reply to Extended Release Seroquel Approved For Depression, posted by Phillipa on December 8, 2009, at 20:19:59
I tried this therapy for one month, working up to 250 mg. I was tired all the time and it did not touch my depression.
Doctor wanted me to stabilize on 300mg, couldn't get there and stopped.
Posted by Phillipa on December 8, 2009, at 21:45:23
In reply to Re: Extended Release Seroquel Approved For Depression, posted by RSidney on December 8, 2009, at 20:39:56
One day of 50mg and the docs pulled me off it as couldn't talk the words wouldn't come out. Phillipa
Posted by bleauberry on December 9, 2009, at 17:35:57
In reply to Extended Release Seroquel Approved For Depression, posted by Phillipa on December 8, 2009, at 20:19:59
>
>release. "Seroquel XR may provide another >effective treatment option for the depressive >symptoms associated with MDD as adjunctive >treatment to antidepressants."Notice the word "may" in the above sentence. Typical CYA political language. We are the guinnea pigs to show them if that word "may" could actually be "will" or "will not". At this point, they don't know. But for sure they are looking for a new angle to increase sales.
>
> The FDA's action was based on data from 2 phase 3 clinical studies of 939 patients with refractory MDD, showing that the addition of extended-release quetiapine to antidepressant therapy yielded significantly greater reductions in Montgomerey-Asberg Depression Rating Scale total score.More details please. What were the antidepressants? What were the AD doses? What subtypes of depression are we talking about? But here's the real question. Those depression scores involve a total of a bunch of subgroups. For example, there is a score for "interest, activities, hobbies"; a score for "sleep"; a score for "appetite"; a score for "energy"...and so on. A bunch of subgroups that get scored. I want to see more details. Did the interest, motivation scores increase? I doubt it. The people were too sedated for that. Energy increased? I doubt it. Mood improved? I doubt it. They were probably drugged and cared less, so in a sense that improved their score of "overall wellbeing". Where did most of the total score get its increase from? Probably just two things...sleep and appetite.
Of course, some people are helped immensely by Seroquel. I just don't hardly ever see it, but it happens once in a while.
>
> Adverse events most commonly reported in study patients receiving quetiapine were consistent with the drug's profile and included somnolence (150 mg/day, 37%; 300 mg/day, 43%), dry mouth (150 mg/day, 27%; 300 mg/day, 40%), fatigue (150 mg/day, 300 mg/day, 14%; 11%), and constipation (150 mg only, 11%).Yep, if someone needs to be drugged up and serene, that would probably do it. Kind of hard to feel depression through that.
>
> Other potential adverse events related to use of the atypical antipsychotic may include rapid weight gain, tardive dyskinesia, suicidal thinking and behavior, neuroleptic malignant syndrome, hyperglycemia, increased cholesterol levels, leukopenia, neutropenia, and agranulocytosis.Lovely.
>
> Quetiapine extended-release tablets previously were approved for the treatment of schizophrenia, depressive episodes of bipolar disorder, manic or mixed episodes of bipolar disorder as either monotherapy or adjunct therapy to lithium or divalproex, and the maintenance treatment of bipolar disorder as adjunct therapy to lithium or divalproex.
>
> Other indications currently under FDA review include acute monotherapy and maintenance monotherapy for the treatment of MDD in adult patients.
>Gotta get those sales up. Find other uses. Hey, how about anorexia? How about oncology insomnia, or oncology management in general? I wonder, do people pee easier on seroquel? Maybe that would be something.
It's a friggin antihistamine above and beyond anything else it does for pete's sake.
Seroquel is a miracle for a minority of people, and for them this post is not intended, forgiveness is requested.
Posted by Phillipa on December 9, 2009, at 20:53:01
In reply to Re: Extended Release Seroquel Approved For Depression, posted by bleauberry on December 9, 2009, at 17:35:57
It's a study not fact. Phillipa
Posted by bleauberry on December 11, 2009, at 22:27:36
In reply to Re: Extended Release Seroquel Approved For Depression » bleauberry, posted by Phillipa on December 9, 2009, at 20:53:01
> It's a study not fact. Phillipa
Exactly!
That was my point.
Thank you.
Posted by morganator on December 12, 2009, at 2:19:08
In reply to Re: Extended Release Seroquel Approved For Depression, posted by bleauberry on December 9, 2009, at 17:35:57
I felt like I was tripping when I took seroquel. It's pretty sad that it is being pushed the way it is. I'm now seeing the ads on tv for it. Seroquel is one of the last drugs that should be advertised in this way.
Posted by SLS on December 12, 2009, at 5:20:52
In reply to Extended Release Seroquel Approved For Depression, posted by Phillipa on December 8, 2009, at 20:19:59
> FDA Approves Extended-Release Quetiapine as Add-On Treatment of Depression
It looks like AstraZeneca got lucky on this one. I think they acted early enough to give the appearance that their drug is somehow more antidepressant-like than the other atypical antipsychotics. That's not to say that Seroquel is without beneficial effect when treating depression for a subset of people. However, the same claim could be made for the other atypical antipsychotics. Perhaps it is the 5-HT2a antagonism that these drugs share that is most important in their antidepressant effect. Abilify was the first of these drugs to be approved for antidepressant augmentation. However, there are differences between these drugs, too. One must consider that Seroquel has a major metabolite that is a norepinephrine reuptake inhibitor; a property that some classic antidepressants share.
Seroquel made me feel irritable and perhaps slightly dysphoric. However, I watched someone experience an energizing antidepressant effect within two hours of adding Seroquel to her treatment regime. Her diagnosis is questionable, though. It is difficult to place her with respect to polarity. She did experience major depressive episodes, but psychotic mixed states were more prominent. Since the introduction of Seorquel, she has been stable, productive, and employed.
I think the problem with touting Seroquel as an antidepressant augmenter is one of perspective. I'm sure it can act as one, but under what circumstances does one introduce it in treatment? What is the percentage of people that it helps? Are there certain case profiles for which it is best suited? What is the risk versus benefit of using Seroquel for depression?
- Scott
Posted by Phillipa on December 12, 2009, at 20:09:04
In reply to Re: Extended Release Seroquel Approved For Depression, posted by SLS on December 12, 2009, at 5:20:52
I agree. Me myself could not take even 12.5mg without falling dead asleep. One day in the hospital and the docs took me off of it. Phillipa
Posted by Ron Hill on December 16, 2009, at 0:14:55
In reply to Re: Extended Release Seroquel Approved For Depression, posted by SLS on December 12, 2009, at 5:20:52
> One must consider that Seroquel has a major metabolite that is a norepinephrine reuptake inhibitor; ...
Scott,
Due to the NRI metabolite, does this mean that Seroquel should not be combined with an MAOI, like Nardil or Parnate, due to the risk of a hypertensive crisis?
-- Ron
PS If you can't reply right now due to your pain of Parnate withdrawal, I understand.
Posted by SLS on December 16, 2009, at 6:27:27
In reply to Re: Extended Release Seroquel Approved For Depression » SLS, posted by Ron Hill on December 16, 2009, at 0:14:55
> > One must consider that Seroquel has a major metabolite that is a norepinephrine reuptake inhibitor; ...
>
> Scott,
>
> Due to the NRI metabolite, does this mean that Seroquel should not be combined with an MAOI, like Nardil or Parnate, due to the risk of a hypertensive crisis?
>
> -- Ron
>
> PS If you can't reply right now due to your pain of Parnate withdrawal, I understand.I don't know. One might speculate that if the NRI desipramine is compatable with MAOIs, so might be Seroquel. I am having a hard time remembering anyone that has tried it. If one were to attempt to add Seroquel to an ongoing treatment with a MAOI, it would be prudent to titrate the dosage of the Seroquel carefully.
- Scott
Posted by cee on December 17, 2009, at 14:31:56
In reply to Re: Extended Release Seroquel Approved For Depression » Ron Hill, posted by SLS on December 16, 2009, at 6:27:27
> > > One must consider that Seroquel has a major metabolite that is a norepinephrine reuptake inhibitor; ...
> >
> > Scott,
> >
> > Due to the NRI metabolite, does this mean that Seroquel should not be combined with an MAOI, like Nardil or Parnate, due to the risk of a hypertensive crisis?
> >
> > -- Ron
> >
> > PS If you can't reply right now due to your pain of Parnate withdrawal, I understand.
>
> I don't know. One might speculate that if the NRI desipramine is compatable with MAOIs, so might be Seroquel. I am having a hard time remembering anyone that has tried it. If one were to attempt to add Seroquel to an ongoing treatment with a MAOI, it would be prudent to titrate the dosage of the Seroquel carefully.
>
>
> - ScottGOOD DAY
Iam taking 750mg a day for anxiety deppression and my pdoc is talking about adding parnate to the mix, but after reading some of the posts i will be asking him about the saftey of the two
The seroquel has knocked down my depression but has still left me with anxiety that comes and goesthanks for the great posts
cee
Posted by SLS on December 17, 2009, at 16:02:16
In reply to Re: Extended Release Seroquel Approved For Depression, posted by cee on December 17, 2009, at 14:31:56
One case study looked at the combination of Nardil with low-dose Seroquel. No dangerous interactions were reported.
http://www.theannals.com/cgi/content/abstract/40/3/567
- Scott
Posted by cee on December 20, 2009, at 17:40:57
In reply to Re: Extended Release Seroquel Approved For Depression, posted by SLS on December 17, 2009, at 16:02:16
HELLO PEOPLE
Iam taking 750mg of seroquel xr and i want to start parnate does anybody else tried this combo for hard to treat depression i think that 750 seroquel might be to much any , any thoughtspeace
cee
Posted by floatingbridge on December 21, 2009, at 2:19:00
In reply to Extended Release Seroquel Approved For Depression, posted by Phillipa on December 8, 2009, at 20:19:59
I'm late to the thread, but I've noticed the NYT website ad blitz for seoquel xr--touted as an 'antidepressant'--appears on page after page. Can't help but note the slippage of terms. I don't think 'AP' would be as sellable.
Seroquel was the worst med for me--awful restless, gotta jump out of my body sensation. Unbearable. I know it helps many here, though. Everyone is different.
best,
fb
Posted by Phillipa on December 21, 2009, at 19:09:05
In reply to Re: Extended Release Seroquel Approved For Depress » Phillipa, posted by floatingbridge on December 21, 2009, at 2:19:00
Fb couldn't tolerate it either. Taken off after one day. Love Phillipa
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