New Data Suggests Doctors Might Not Be Considering Depression Symptoms That Are Important to Patients, Such as Pain and Anxiety

VIENNA, 16 October 2007 - Doctors and depressed patients judge symptom severity and improvement following pharmacotherapy differently, according to data presented today at the 20th Annual Meeting of the European College of Neuropsychopharmacology (ECNP) in Vienna, Austria. The data suggest physicians might not be considering symptoms that are important in the eyes of patients, such as pain and anxiety.1

The results are based on a post-hoc analysis of a double-blind, placebo-controlled, multi-center European study in adults with major depressive disorder (MDD) and non-specific pain (n=327). This analysis aimed to compare how patients and physicians estimate overall disease severity at baseline and symptom improvement during short-term treatment of major depression, regardless of treatment group.1 Results showed that physicians treating these patients consider only physician-rated depressive symptoms (as assessed by the Montgomery-Asperg-Depressions Scale or MADRS) when assessing how sick the patient is and whether the patient is getting better. Patients, on the other hand also consider pain and anxiety when judging their own improvement.1

“Previous evidence has suggested that treating both the emotional and the physical symptoms of depression provides patients with the best chance of reaching remission,” said Professor Koen Demyttenaere, Department of Psychiatry, University Hospital Gasthuisberg, Leuven, Belgium and lead author of this study. “These qualitative results highlight the need for physicians to also consider a broad spectrum of symptoms including pain and anxiety when treating patients with Major Depressive Disorder and associated pain.”

Study results
The two main findings of this new analysis are:
Disease Severity: At the beginning of the study, physician assessment of the overall disease severity was significantly predicted by depression severity (using the MADRS evaluation tool) and paranoid ideation (as measured by the Symptom Checklist, or SCL-90-R); pain was not a consideration.1 After eight weeks of treatment, physicians’ assessment of overall disease severity was significantly predicted by decrease in depression severity (MADRS), being female and of younger age. Among physicians, pain again was not predictive of disease severity.1
Disease Improvement: Among physicians, overall disease improvement at study end, measured by the Clinical Global Impression of Improvement scale (CGI-I), was significantly positively predicted by decrease in MADRS-rated severity; by decrease in distress in interpersonal sensitivity (measured by the SCL-90-R); and negatively predicted by an older age.1 In contrast, patient rated improvement included improvement in pain. Significant predictors of patient-assessed improvement (as measured by the Patient Global Impression of Improvement scale) were a decrease in pain severity (based on average pain, as measured by the Brief Pain Inventory scale or BPI) depression and anxiety according to SCL-90-R subdomains.1
Furthermore, in this study, the similarity of patient rated disease improvement (PGI-I) and physician rated disease improvement (CGI-I) was investigated by descriptive statistics and a prediction model. In 44.7 percent of cases there was a discrepancy in improvement assessments. In cases of discrepancy, the mean improvement was usually judged higher by physicians than patients (36.3 percent versus 8.4 percent) irrespective of treatment. A lower decrease in MADRS assessed depression severity, pain interference in relation with other people and in interpersonal sensitivity significantly predicted a lower discrepancy between patient and physician improvement. A lower decrease in patient rated pain severity (BPI) and depression (SCL-90-R) significantly predicted a higher discrepancy between physician and patient rated improvement, with the physician rating improvement being higher.

These results provide evidence on the relative importance of different symptoms in depression from a patient perspective and the need to focus beyond core depressive symptoms, when treating depressed patients.

Notes to Editors:

About the Study1
Methodology
Data were derived from a double-blind, placebo-controlled, multi-center study conducted in Belgium, Finland, France, Germany and Slovakia in outpatients ?18 years of age who presented with major depressive disorder (baseline disease severity defined as a Montgomery-Asberg Depression Rating Scale [MADRS] ?20 and Clinical Global Impression-Severity [CGI-S] scale ?4) and moderate pain not attributable to a diagnosed organic pain syndrome (Brief Pain Inventory-Short Form [BPI-SF] average pain score ?3). Physicians were asked to rate severity of depression by using the MADRS, CGI-Severity and Improvement scales. Patients were asked to assess pain using the BPI-SF, psychological symptomatology (including depression) with the symptom checklist 90 items revised (SCL-90-R), and overall improvement after pharmacotherapy with the Patient Global Impression of Improvement (PGI-I). Using a five percent threshold, multivariate regressions were performed as post-hoc analyses to identify predictors of disease assessment at baseline and at the end of the study (LOCF). The study was sponsored by Eli Lilly and Company and Boehringer Ingelheim GmbH.

About Depression
Major Depressive Disorder (MDD) affects approximately 121 million people worldwide.2 The World Health Organization estimates depression will be among the highest-ranking causes of disability in developed countries by 2020, second only to ischemic heart disease worldwide.3 It can happen to anyone of any age, race or ethnicity; however, women are nearly twice as likely to experience depression as men.4 Although it is one of the most frequently seen psychiatric disorders in the primary care setting,5,6 it often goes undiagnosed or is under-treated.2,7 This might be because depressed people often present with physical symptoms rather than emotional complaints; in one large study, 69 percent of patients with MDD reported only physical symptoms as the reason for visiting their physician.8

Complete elimination of symptoms, or remission, is the primary goal of depression treatment. Treating the full spectrum of emotional and physical symptoms to remission significantly decreases a patient’s risk of relapse.9

Eli Lilly and Company and Boehringer Ingelheim
In November 2002, Eli Lilly and Company and Boehringer Ingelheim signed a long-term agreement to jointly develop and commercialize duloxetine hydrochloride. This partnership covers neuroscience indications in most countries outside of the United States and Japan, with few exceptions.

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world`s most urgent medical needs.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and

38,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2006, Boehringer Ingelheim posted net sales of 10.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.  
 
 
Contact:
Boehringer Ingelheim GmbH
Ute E. Schmidt
55216 Ingelheim
Germany
Phone: +49 (0)6132 7797296
Fax: +49 (0)6132 776601
E-mail 

Eli Lilly and Company
David Shaffer
USA
Phone: +1-317-651-3710
 

References:
1 Demyttenaere KD, et al. Patient-versus Physician-assessed Disease Severity and Outcomes in Patients with Non- specific Pain Associated with Depression
2 World Health Organization. Factsheet - Depression, 2005. Available at: http://www.who.int/mental_health/management/depression/definition/en/. Last visited 26 April 2007
3 Murray CJL, Lopez AD, eds. The Global Burden of Disease; 1996.
4 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed., Text Revision. Washington DC: American Psychiatric Association; 2000:345-428.
5 Ormel J, et al. Common mental disorders and disability across cultures: results from the WHO Collaborative Study on Psychological Problems in General Health Care. JAMA. 1994;272:1741–1748.
6 Spitzer RL, et al. Utility of a new procedure for diagnosing mental disorders in primary care: the PRIME-MD 1000 study. JAMA. 1994;272:1749–1756.
7 Ormel J, Koeter MWJ, van den Brink W, van de Willige G. Recognition, management, and course of anxiety and depression in general practice. Arch Gen Psychiatry. 1991;48:700–706.
8 Simon GE et al. An International Study of the Relation Between Somatic Symptoms and Depression. New Engl J Med. 1999;341(18):1329-35.
9 Paykel ES, et al. Psychol Med. 1995;25(6):1171-1180. 

Posted: October 2007

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