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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 jrbecker on February 26, 2003, at 13:19:12
see below or call 1-877-CTLILLY (1-877-285-4559)...
Open-Label Treatment with Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients with Major Depression
This study is not yet open for patient recruitment.
Sponsored by
Eli Lilly and Company
PurposeThe purposes of this study are to determine:
The safety of duloxetine and any side effects that might be associated with it.
Whether duloxetine can help patients with major depression.
The safety associated with switching from a medication you may be taking for depression to taking duloxetine.
It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.
Condition Treatment or Intervention Phase
Major Depressive Disorder Drug: duloxetine Phase IIIMEDLINEplus related topics: Mental Health
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy StudyEligibility
Ages Eligible for Study: 18 Years and above , Genders Eligible for Study: Both
Criteria
Inclusion Criteria:You must be at least 18 years old.
You must have been diagnosed with major depressive disorder.
You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 14 weeks
Exclusion Criteria:You are a woman and are pregnant or breastfeeding.
You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
You have had a primary diagnosis of an anxiety disorder within the past 6 months.
You have a history of alcohol or drug dependence or abuse within the past 6 months.
Location and Contact InformationCall Center 1-877-CTLILLY (1-877-285-4559)
California
Los Angeles, California, United States
Carisbad, California, United States
Stanford, California, United States
Connecticut
Cromwell, Connecticut, United States
Florida
Coral Springs, Florida, United States
Gainesville, Florida, United States
Miami, Florida, United States
Georgia
Atlanta, Georgia, United States
Maine
Bangor, Maine, United States
Massachusetts
Boston, Massachusetts, United States
New York
Rochester, New York, United States
New York, New York, United States
Ohio
Cincinnati, Ohio, United States
Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Texas
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Virginia
Falls Church, Virginia, United States
Richmond, Virginia, United States
Charlottesville, Virginia, United States
Washington
Seattle, Washington, United States
Wisconsin
West Allis, Wisconsin, United States
More InformationStudy ID Numbers 6476
Study Start Date December 2002; Estimated Completion Date December 2003
Record last reviewed August 2002
NLM Identifier NCT00042562
ClinicalTrials.gov processed this record on 2003-02-26
Posted by Jack Smith on February 26, 2003, at 14:09:11
In reply to open-label duloxetine trials coming soon, posted by jrbecker on February 26, 2003, at 13:19:12
If they are interested in doing more clinical studies, this seems to point to a fact that they are having trouble getting approval . . .
Posted by Jack Smith on February 26, 2003, at 14:31:43
In reply to open-label duloxetine trials coming soon, posted by jrbecker on February 26, 2003, at 13:19:12
See the start date below. This study has apparently already begun. Thanks for posting out of date info.
> Study ID Numbers 6476
> Study Start Date December 2002; Estimated Completion Date December 2003
> Record last reviewed August 2002
> NLM Identifier NCT00042562
> ClinicalTrials.gov processed this record on 2003-02-26
>
Posted by jrbecker on February 26, 2003, at 15:18:01
In reply to trials coming soon--NOT SOON, already started., posted by Jack Smith on February 26, 2003, at 14:31:43
Jack, the information below that you referred to is not correct. I have made a call to Lilly and they have confirmed that indeed it has NOT started yet, but will be starting soon. The website only posted this message today (2/26/03), and it is not even posted on the Lilly research website itself. On another note, I don't appreciate the off-handed sarcasm about posting "out-of-date information." Just like everybody else on this site, I'm only here to learn and maybe help share some knowledge along the way.
JRB
> See the start date below. This study has apparently already begun. Thanks for posting out of date info.
>
> > Study ID Numbers 6476
> > Study Start Date December 2002; Estimated Completion Date December 2003
> > Record last reviewed August 2002
> > NLM Identifier NCT00042562
> > ClinicalTrials.gov processed this record on 2003-02-26
> >
>
>
Posted by Jack Smith on February 26, 2003, at 15:35:04
In reply to Re: just called Lilly - it has NOT started yet, posted by jrbecker on February 26, 2003, at 15:18:01
Sorry about that, you are right about the sarcasm, unnecessary. On a related note, did Lily have anything to say about when the stuff is going to be released to the general public? Also, did you express an interest in being in the trial? If so, how was that received?
Posted by jrbecker on February 26, 2003, at 23:23:06
In reply to My apologies, posted by Jack Smith on February 26, 2003, at 15:35:04
No, I didn't ask on the timing of the approvability process. Since I was speaking to just a general operator at their help line, I assumed she wouldn't have any details on that issue. In talking to colleagues in the pharm biz and from reading up on the industry reports, it still seems anybody's guess when it might be approved. Lilly is preparing for an FDA tour of their facilities this spring, and I am told that this somehow has a bearing on their compounds that are in the approval process. It seems final approval is contingent upon labeling discussions and resolution of the company's outstanding manufacturing issues -- something possibly being investigated while the FDA is on site [yet I myself am not quite clear on this].
If I had to predict a date myself I would believe that it's in the next 3-6 months in terms of a release to the public.
The FDA has a made a big to-do lately of saying that they are trying to speed up the approval process for drug releases. Who knows whether this new PR-spin has any effect on duloxetine's fate.
But what I do know from participating in a couple of clinical trials is this: never judge a drug's efficacy based on its difficulty of passing FDA standards. Most of the hang-ups that delay, and sometimes even deny, drugs from approvability are much more related to the methodological issues of the study more than anything else. In taking advanced stats back in college and trying to design and carry out my own studies, I certainly got a taste for this first hand.
As for inquiring about whether I could participate in the trial - I didn't ask. Despite a good run with Effexor for two and a years, the SNRIs are probably not the best treatment for my specific symptoms. Although I'm always up for a trial of anything, so who knows.
If I come across, any updates, I'll let you know.
In the meantime, you might want to consider combining Strattera (a NARI, and also another Lilly med) with your favorite SSRI. This will give you a rough equivalent of what duloxetine might do for you (but on the other hand, who knows, every med is so different depite even slight tweaking of the molecules). But this way, you get to tailor the NE and 5HT ratio to your liking.>Sorry about that, you are right about the sarcasm, unnecessary. On a related note, did Lily have anything to say about when the stuff is going to be released to the general public? Also, did you express an interest in being in the trial? If so, how was that received?
This is the end of the thread.
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