November 20, 2006

Seroquel For Bipolar Disorder And Oh So Much More

In recent posts, I have noted that AstraZeneca is pushing hard to turn Seroquel into the equivalent of Lithium--the go-to, gold standard, front line monotherapy treatment for bipolar disorder. Some readers have wondered whether I wasn't jumping to conclusions and, of course, I wondered myself.

After spending a few hours with a government database over the weekend, I can assure you that I was understating the case: AstraZeneca is now using the term monotherapy in titles of its clinical trials and is even trialing Seroquel directly against Lithium. The Rubicon has definitely been crossed.

What's more, the company is now testing Seroquel on children as young as 4-years-old. And it's conducting studies of the drug not just for bipolar disorder and schizophrenia, as you might expect, but for post-combat PTSD, anxiety disorders, ADHD, cocaine and meth use, alcohol abuse, smoking behavior among schizophrenics and obsessive compulsive disorder.

It's truly breathtaking what the fine folks at AstraZeneca are up to and what so many researchers are willing to do at their behest. Click on the extended entry link for more on these studies, which are so numerous that I'd clutter up the main page.

All of the following data comes directly from ClinicalTrials.gov. Feel free to visit the site and do a search under the term Seroquel (the database includes studies under both brand and generic names). AstraZeneca currently has about 30 of the approximately 180 studies currently underway or recently completed for bipolar disorder. The company also has another 38 studies of Seroquel ongoing, trialing it for other conditions.

Here are some highlights of Seroquel trials:

"Bipolar Maintenance Monotherapy"

"Quetiapine (Seroquel) Maintenance Treatment in Early Onset Bipolar Spectrum Disorders" in 12 to 20 year olds

Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania" in 10 to 17 year olds

Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar Disorder" from the fine folks at Harvard Medical School

The researchers note "This is an exploratory, pilot study, seeking to determine whether Quetiapine is efficacious and well tolerated in the treatment of preschoolers with pediatric bipolar and bipolar spectrum disorder in this age group. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power."

Awesome. Can't wait.

“A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder”

In kids as young as 12-years-old. So much for the wonder years.

"A Study of Quetiapine for the Treatment of Mood Disorders in Adolescents"

"Seroquel in Bipolar Depression Versus Lithium"

Last time I checked, no one claimed that good old Li had strong anti-depressant qualities, so this strikes me as little more than creating a paper AZ can waive in front of doctors and say, "Told ya' it was better than Lithium."

"Phase III Study of Efficacy and Safety Quetiapine Fumarate as Monotherapy"

"Bipolar Maintenance Monotherapy"

A two-year study.

"EMBOLDEN II - Seroquel in Bipolar Depression Versus SSRI"

Seroquel v. Paxil. Which will prove the lesser of two evils?

"Seroquel in the Treatment of Dysphoric Hypomania in Bipolar II"

There are loads of docs who use Seroquel on BPII patients. Efficacy is overkill.

"Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Generalized Anxiety Disorder"

"Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder"

Waking up from Seroquel is like waking up from a fifth of whiskey the night before, so this ought to be fun.

"Quetiapine Added to Oros Methylphenidate [Concerta] in the Treatment of ADHD and Aggressive Behavior"

"High Dose of Quetiapine in Treating Subjects With Treatment Refractory Schizophrenia or Schizoaffective Disorder"

Patients will get up to 1,200 mgs a day for treatment of schizophrenia and schizoaffective disorder. Sounds like the metaphorical equivalent of Thorazine to me.

"Quetiapine for Cocaine Use and Cravings"

A recently completely study right here in the Seattle-Tacoma area.

"A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder With Stimulant Dependence"

Reason enough to quit doing coke and meth.

"Quetiapine Augmentation for Treatment-Resistant PTSD"

Welcome back from Iraq, soldier. Do VA benefits cover diabetes?

"Seroquel on Glucose Metabolism"

Methinks, a certain pharma company is nervous. Good.

"Quetiapine Decreases Smoking in Patients With Chronic Schizophrenia"

Yes, but can I have Seroquel after sex? And will you love me in the morning?

"Quetiapine Augmentation in Severe Obsessive Compulsive Disorder"

I can see it now: patient unable to wake up or focus. Their OCD is cured.

"Comparison of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients With Schizophrenia and Schizoaffective Disorder"

An Eli Lilly study measuring Zyprexa versus Seroquel. A study made for sales reps.

All of the above is but a sample of hte trials of Seroquel.

Posted by Philip Dawdy at November 20, 2006 01:03 AM
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Comments

Unbelievable. You know maybe the pharma people should look into the bottled water industry.
We could choose Li water, or Seroquel water.
Just open a bottle in the morning, drink up and it will cure what ails you.

Posted by: Stephany at November 20, 2006 11:03 AM

G-R-E-A-T post. I had an idea about Seroquel making it into the water supply, but Stephany clearly beat me to the point. One must wonder how many of these studies are designed to show anything useful versus how many of them are designed to make neat journal article reprints with which drug reps can "educate" physicians. Of these many studies, some will not show results in Seroquel's favor, and one has to wonder if these results will ever see the light of day.

Posted by: CL Psych at November 20, 2006 01:33 PM

This is nauseating.

Posted by: Priscilla at November 26, 2006 01:06 AM

Personal trial of Seroquel as monotherapy.

It failed miserably.

Now at the 7 week mark, this is where, I, if part of an official trial would have checked myself out of the study.

Anxiety: worse.

Insomnia: returned, even on higher doses. Seems to be that the longer on it, the more I needed to get decent sleep.

Bipolar mania: increased. Suicidal ideations increased, with use of Seroquel.

Heart issues and ER visit: check the box that says YES. I have never been to an ER except for stitches. Never went to an ER thinking I was having a heart attack. This happened while on Seroquel. Anyone else suspect the Seroquel as the culprit? I do.
This stuff sucks. Anyone who said so, is right.
Wish I didn't have to find out the hard way. I can hardly wait to see how fun the withdrawal is gonna be.

Posted by: Stephany at November 28, 2006 01:20 PM

I have to get back to you, but listen to this: I "graduated" to Seroquel about eight years ago.
It's "better" than Risperdal. I am a 47-year-old
with a voracious appetite for sex, but nowadays
I never seem to achieve. The medical and the
substance abuse establishment will be happy to
tell someone like me that my problem "achieving" is due to alcohol use. Better to blame that problem on spirits than blame it on cutting-edge
psychiatric drugs like Seroquel and other drugs
in that class. Anyone know how that class-action
suit against Astra is going, the one about possible carcinogenic effects in Seroquel? It's probably better for me than aspartame.
........

Posted by: David S. at December 19, 2006 08:04 PM

Can some people deal with alcohol and other drugs better than others? WBR LeoP

Posted by: Leo at January 19, 2007 01:13 PM

thanks for your article. i have taken seroquel for about 3 years , i started on thorazine in detox and then they put me on seroquel in rehab.. waking up at times is reminiscnent of my hangover days tho i don't credit seroquel for my sobriety. I know that they say its not habit forming but i tried to get off of it on my own and i was only taking 100mg at bedtime and i was nearly suicidal.. i went back on after about 3 weeks because i could NOT SLEEP.. I SLEPT HARDLY ANY IN THREE WEEKS. That was about 5 monthes ago. Now like the good bi-polar drug addict that i am.. i discovered i had some Thorzine in a cabinet and I have been at least for about 2 weeks taking 50mg of thorazine with 50mg of Seroquel.. i Sleep great and I feel much calmer through the day. much better than with the seroquel only... Plus AstroZeneca has some nerve for what they charge. . .. I comptley disagree on giving this drug to a small child... I am the practice manager for a well established Pediatrician and he won't he even monitor the med for a psychiatrist if the kids is not at least 12...

Posted by: kristin matheney at March 1, 2007 07:00 PM

I have been on lithium since 1992 its basically the only medication that has leveled me with bipolar. I am now experiencing long term and short term memory loss. What happens when it gets to where i don't remember my name, do i have to be institutionalized? They warn about these things on the medication bottle but never heard of any cases please if anyone has experinced the same things please email me.

Posted by: Dawn at April 3, 2007 01:39 PM

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