lillytrials.com ..not much about Prozac 'praps they forgot to post it rofl

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Mental Health/Neuroscience

http://www.lillytrials.com/results/by_ta/results_cns.html

Consistent with the company's policy of public data disclosure, this

clinical trial results section includes result summaries of

completed Phase 1 through Phase 4 Lilly-sponsored clinical studies

conducted on Lilly marketed products since July 1, 2004. For Phase

1, 2, and 3 clinical trials, Lilly discloses results when a

drug's

indication is approved and it is commercially available. Phase 3

trial results for secondary indications of marketed drugs that fail

to support the hypothesis being tested, or which are contrary to the

intended outcome, will be disclosed as soon as possible after the

data analysis is completed but no later than 1 year after the trial

has completed. For Phase 4 clinical trials, Lilly discloses the

results as soon as possible after the data analysis is completed but

no later than 1 year after the trial has completed. For studies that

are under review by peer-reviewed journals that prohibit pre-

publication results disclosure, the results will be posted on the

registry at the time of the publication.

In addition, summaries of the results of core safety and efficacy

registration trials for Lilly products and indications approved

since July 1, 1994 will be made available. Results will be posted by

Lilly whether they are favorable or unfavorable to any Lilly product.

Included are trial result summaries that are completed to date. The

company will continue to disclose additional summaries and

publication citations as they become available.

Trial Results

The following trials have been conducted for products in the mental

health/neuroscience therapeutic area.

Drug Disease Trial ID Trial Title Trial

Phase Results Citations

Cymbalta for Major Depressive Disorder (MDD)

Cymbalta Major Depressive Disorder (MDD) 3327a Duloxetine Versus

Placebo in the Treatment of Major Depression

2 3327a Results 3327a Citations

Cymbalta Major Depressive Disorder (MDD) 3327b Duloxetine Versus

Placebo in the Treatment of Major Depression

2 3327b Results 3327b Citations

Cymbalta Major Depressive Disorder (MDD) 4091a Duloxetine Versus

Placebo and Paroxetine in the Acute Treatment of Major Depression

3 4091a Results

Cymbalta Major Depressive Disorder (MDD) 4091b Duloxetine Versus

Placebo and Paroxetine in the Acute Treatment of Major Depression

3 4091b Results 4091b Citations

Cymbalta Major Depressive Disorder (MDD) 4092 Long-Term Open-Label

Treatment with Duloxetine Hydrochloride for Evaluation of Safety in

Major Depression

3 4092 Results 4092 Citations

Cymbalta Major Depressive Disorder (MDD) 4689a Duloxetine Once-Daily

Dosing Versus Placebo in the Acute Treatment of Major Depression

3 4689a Results 4689a Citations

Cymbalta Major Depressive Disorder (MDD) 4689b Duloxetine Once-Daily

Dosing Versus Placebo in the Acute Treatment of Major Depression

3 4689b Results 4689b Citations

Prozac for Pediatric Depression

Prozac Pediatric Depression 236 Fluoxetine: Fluoxetine Versus

Placebo in Adolescent Depressed Patients

3 236 Results 236 Citations

Prozac Pediatric Depression 375 Fluoxetine Versus Placebo in the

Acute Treatment of Major Depressive Disorder in Children and

Adolescents 3 375 Results 375 Citations

Prozac Pediatric Depression 2201 Fluoxetine Versus Placebo in

Childhood/Adolescent Depression

3 2201 Results 2201 Citations

Prozac Pediatric Depression 3032 Fluoxetine Versus Placebo in the

Treatment of Children and Adolescents with Obsessive-Compulsive

Disorder

3 3032 Results 3032 Citations

Prozac Pediatric Depression 1545 Pharmacokinetic Assessment of

Fluoxetine and Norfluoxetine in Preadolescent and Adolescent

Patients 4 1545 Results 1545 Citations

Strattera for Attention Deficit/Hyperactivity Disorder (ADHD)

Strattera Attention-Deficit/Hyperactivity Disorder (ADHD) 634 Safety

and Pharmacokinetic Study of Tomoxetine Hydrochloride in Pediatric

Patients with ADHD

1 634 Results 634 Citations

Strattera Attention-Deficit/Hyperactivity Disorder (ADHD) 1585 A

Randomized, Double-Blind Study of Tomoxetine Hydrochloride,

Methylphenidate Hydrochloride, and Placebo in Pediatric Outpatients

with Attention Deficit/Hyperactivity Disorder

2 1585 Results 1585 Citations

Strattera Attention-Deficit/Hyperactivity Disorder (ADHD) 1586 A

Randomized, Double-Blind Study of Tomoxetine Hydrochloride,

Methylphenidate Hydrochloride, and Placebo in Pediatric Outpatients

with Attention-Deficit/Hyperactivity Disorder

2 1586 Results 1586 Citations

Strattera Attention-Deficit/Hyperactivity Disorder (ADHD) 1855

Randomized, Double-Blind, Placebo-Controlled, Variable

Discontinuation Study of Tomoxetine Hydrochloride in Children with

Attention-Deficit/Hyperactivity Disorder

2 1855 Results 1855 Citations

Strattera Attention-Deficit/Hyperactivity Disorder (ADHD) 2097 Long-

Term, Open-Label, Safety Study of Tomoxetine Hydrochloride in

Patients, 6 Years and Older 2 2097 Results

Strattera Attention-Deficit/Hyperactivity Disorder (ADHD) 2553 A

Randomized, Double-Blind, Placebo- and Comparator-Controlled Study

of Tomoxetine Hydrochloride in Recreational Drug Users

3 2553 Results 2553 Citations

Strattera Attention-Deficit/Hyperactivity Disorder (ADHD) 2556 A

Phase III Randomized, Double-Blind Comparison of Placebo and

Atomoxetine Hydrochloride in Adult Outpatients with DSM-IV Attention-

Deficit/Hyperactivity Disorder.

3 2556 Results 2556 Citations

Strattera Attention-Deficit/Hyperactivity Disorder (ADHD) 2561 A

Phase III Open-Label Safety and Efficacy Study of Tomoxetine

Hydrochloride in Outpatients with ADHD, Ages 6 to 18 Years 3 2561

Results

Strattera Attention-Deficit/Hyperactivity Disorder (ADHD) 3468 A

Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and

Safety Comparison of Fixed-Dose Ranges (mg/kg/day) of Tomoxetine

with Placebo in Child and Adolescent Outpatients with ADHD, Aged 8

to 18 Years

3 3468 Results 3468 Citations

Strattera Attention-Deficit/Hyperactivity Disorder (ADHD) 4642 A

Phase III Randomized, Double-Blind Comparison of Placebo and

Tomoxetine Hydrochloride in Adult Outpatients with DSM-IV Attention-

Deficit/Hyperactivity Disorder. 3 4642 Results 4642 Citations

Strattera Attention-Deficit/Hyperactivity Disorder (ADHD) 5197 A

Phase 3 Open-Label Safety and Efficacy Study of Tomoxetine

Hydrochloride in Pediatric Outpatients (6 to 18 Years) with ADHD 3

5197 Results

Strattera Attention-Deficit/Hyperactivity Disorder (ADHD) 5670 A

Randomized, Double-Blind, Placebo-Controlled Trial of Once Daily

Atomoxetine Hydrochloride to Evaluate Efficacy in the Treatment of

Attention-Deficit/Hyperactivity Disorder in Children Ages 6-12 with

an Assessment of Evening Behavior 3 5670 Results 5670 Citations

Strattera Attention-Deficit/Hyperactivity Disorder (ADHD) 2746

Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine

Hydrochloride versus Placebo in Children with Attention-

Deficit/Hyperactivity Disorder

4 2746 Results 2746 Citations

Symbyax for Bipolar Disorder

Symbyax Bipolar Disorder 3077a Placebo-Controlled Olanzapine

Monotherapy in the Treatment of Bipolar I Depression 3 3077a Results

3077 Citations

Zyprexa for Bipolar Disorder

Zyprexa Bipolar Disorder 1028 Olanzapine Versus Placebo in the

Treatment of Mania Associated with Bipolar I Disorder

3 1028 Results 1028 Citations

Zyprexa Bipolar Disorder 1035a Olanzapine Added to Mood Stabilizer

in the Treatment of Bipolar Disorder 3 1035a Results 1035 Citations

Zyprexa Bipolar Disorder 1035b Olanzapine Added to Mood Stabilizer

for Relapse Prevention in Patients With Bipolar Disorder

3 1035b Results

Zyprexa Bipolar Disorder 1729 Olanzapine Versus Placebo in the

Treatment of Bipolar Disorder, Manic or Mixed 3 1729 Results 1729

Citations

Zyprexa Bipolar Disorder 2055 Olanzapine Versus Haloperidol in the

Treatment of Acute Mania

3 2055 Results 2055 Citations

Zyprexa Bipolar Disorder 2551 Olanzapine Versus Divalproex in the

Treatment of Acute Mania

3 2551 Results 2551 Citations

Zyprexa for Schizophrenia

Zyprexa Schizophrenia 917 A Fixed-Dose Range Safety and Efficacy

Study of Olanzapine Versus Haloperidol in the Treatment of

Schizophrenia

2 917 Results 917 Citations

Zyprexa Schizophrenia 978 Olanzapine Versus Placebo and Haloperidol

in the Treatment of Schizophrenia

2 978 Results 978 Citations

Zyprexa Schizophrenia 980 Olanzapine Versus Haloperidol in the

Treatment of Schizophrenia and Other Psychotic Disorders

3 980 Results 980 Citations

Zyprexa Schizophrenia 982 Fixed-Dose Olanzapine Versus Placebo in

the Treatment of Schizophrenia

3 982 Results 982 Citations

Zyprexa Schizophrenia 1960 Olanzapine Relapse Prevention Versus

Placebo in the Treatment of Schizophrenia

3 1960 Results 1960 Citations

Copyright © 2004 Eli Lilly and Company | All rights reserved |

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>

> Lilly Issues Response to British Medical Journal

> Friday December 31, 3:12 pm ET

>

>

> INDIANAPOLIS, Dec. 31 /PRNewswire-FirstCall/ -- In response to the

> British Medical Journal article dated January 1, 2005,

entitled " FDA

> to review missing drug company documents, " Eli Lilly and Company

has

> issued the following statement:

> ADVERTISEMENT

>

>

> To our knowledge, there has never been any allegation of missing

> documents from the Wesbecker trial or any other trial involving

> Lilly. Further, it has always been Lilly's objective to publicly

> disclose data about both the safety and efficacy of fluoxetine.

> Lilly has made several requests to the BMJ to obtain copies of the

> supposed " missing " documents; we still await these documents. We

are

> surprised and concerned that a leading medical journal would not

> find it important to share these documents with us so that we

could

> respond to the public in a meaningful way.

>

> The BMJ article addresses " activation syndrome. " It is important

to

> point out that Lilly has published widely in the area of

activation

> syndrome as it relates to fluoxetine. Lilly has consistently

> provided regulatory agencies worldwide with results from both

> clinical trials and post marketing surveillance (safety monitoring

> after drug approval), including those related to fluoxetine. Based

> on this, Lilly believes that there is no new scientific

information

> to review on this topic. In addition, contrary to what is stated

in

> the BMJ article, it is well established scientifically that

> fluoxetine does not act in the same manner as cocaine.

>

> Lilly believes in full and appropriate disclosure of clinical

trial

> data and recently underscored this commitment through the launch

of

> Lilly's clinical trial registry database, www.lillytrials.com,

which

> was noted as being as among the most comprehensive database to

date

> of its kind in the industry. Lilly is committed to the health and

> safety of all patients being treated with our medicines and to

> ensuring healthcare professionals and families have the

information

> they need to make informed treatment decisions.

>

> (Logo: NewsCom: http://www.newscom.com/cgi-

> bin/prnh/20031219/LLYLOGO )