Clinical trial NCT00036335: Subject Information and Consent Form F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain
Official title: Duloxetine Hydrochloride (LY248686) Protocol F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Pain
Keywords: depression
pain
blues
sadness
aches
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-05-10
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to determine whether an investigational drug can help patients suffering from major depression with pain symptoms, and gather data on the safety of the investigational drug including any side effects that might be associated with it.


Eligibility criteria: Inclusion Criteria:

* You must be suffering from symptoms of depression for at least the past 2 weeks (sadness, loss of interest in daily activities, feelings of hopelessness or guilt, sleeplessness or lack of energy)
* You must have pain symptoms with no known cause, such as unexplainable, head, chest, or back pain, overall aches and pains, or other unexplainable pains.
* You need to be available to visit a doctor's office about once a week for 10 weeks.

Exclusion Criteria:

* You are a woman and are pregnant or breastfeeding.
* You have a current or previous diagnosis of 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.
* You have a serious medical illness.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
state: Arizona
city: Burbank
country: United States
state: California
city: Fresno
country: United States
state: California
city: St. Petersburg
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Oakbrook Terrace
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Glen Burnie
country: United States
state: Maryland
city: Farmington Hills
country: United States
state: Michigan
city: Nashua
country: United States
state: New Hampshire
city: Clementon
country: United States
state: New Jersey
city: Moorestown
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Olean
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Lake Jackson
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Woodstock
country: United States
state: Vermont
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Brown Deer
country: United States
state: Wisconsin
Study officials:
References:
citation: Harada E, Kato M, Fujikoshi S, Wohlreich MM, Berggren L, Tokuoka H. Changes in energy during treatment of depression: an analysis of duloxetine in double-blind placebo-controlled trials. Int J Clin Pract. 2015 Oct;69(10):1139-48. doi: 10.1111/ijcp.12658. Epub 2015 May 16.
citation: Dodd S, Berk M, Kelin K, Zhang Q, Eriksson E, Deberdt W, Craig Nelson J. Application of the Gradient Boosted method in randomised clinical trials: Participant variables that contribute to depression treatment efficacy of duloxetine, SSRIs or placebo. J Affect Disord. 2014 Oct;168:284-93. doi: 10.1016/j.jad.2014.05.014. Epub 2014 Jun 4.