Please select the eligibility criteria that correspond to the clinical trial below.
Title: Brain Morphometric Study in Knee Osteoarthritis Patients Treated With Duloxetine
Brief Summary: This is a two week,single-blind study evaluating pain response and changes in brain imaging upon treatment with placebo in people with knee OA.


Options:
A: Inclusion Criteria:

* Male or female outpatients with osteoarthritis knee pain.

Exclusion Criteria:

* Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
* Acute liver injury (such as hepatitis) or severe cirrhosis.
* Previous exposure to duloxetine.
* Body Mass Index (BMI) over 40.
* Major depressive disorder.
* Daily use of narcotics.
B: Inclusion Criteria:

* Knee pain and osteophytes on radiographs OR
* Knee pain plus patient age of 40 years or older, morning stiffness lasting 30 minutes or less, and crepitus (cracking sound) during motion
* Experiences chronic pain for 6 months or longer
* Average pain rating of worse knee is equal to 4 or greater on a 0-10 scale
* If female, is not pregnant or breast feeding, and not currently attempting to conceive; if of childbearing potential, use of a highly effective method of birth control (as determined by Pl)
* Able to walk at least ½ a city block a day, and agrees to try and slowly increase that over the course of study
* Able to read and speak English and provide informed consent
* Able to understand and comply with all data collection methodology including electronic diary
* Subject agrees to 1) continue their stable drug regimen with no changes during the course of study, 2) only use Tylenol 325 mg of tablets (a maximum of 8 tablets a day) for breakthrough pain, and 3) not use Tylenol or any other pain medicines 12 hours before testing.

Exclusion Criteria:

* Subject takes SNRIs (Savella, Cymbalta, Venlafaxine) or other neuroamine re-uptake blockers for mood disorders
* Subject is allergic to SSRIs, SNRIs, or milnacipran
* Subject has severe or untreated psychiatric disturbance (e.g. mania, depression, anxiety, substance dependence)
* Subject is medicated with 'triptans, MAOIs, SSRIs, other SNRIs, tricyclic or heterocyclic antidepressants, lithium, epinephrine, norepinephrine, clonidine or digoxin during the trial
* Subject has a clinical diagnosis of fibromyalgia
* Subject has severe ongoing or unaddressed medical conditions (e.g. Renal or Hepatic disease \[creatinine\>1.5 ml/dl; AST or ALT\> 3x normal limit\], uncontrolled hypertension, severe cardiac rate or rhythm disorders, rheumatologic disease (e.g. polymyalgia rheumatica), narrow angle glaucoma, hyponatremia, clotting disorders, uncontrolled seizure disorder or urinary retention)
* Subject has cardiac implants
* Subject has a knee replacement
* Subject plans to start new pain treatments or therapies during the study (e.g. new pain medication, injections, PT, surgery)
C: Inclusion Criteria:

* Male or female outpatients with chronic low back pain

Exclusion Criteria:

* Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
* Acute liver injury (such as hepatitis) or severe cirrhosis.
* Previous exposure to duloxetine.
* Body Mass Index (BMI) over 40.
* Major depressive disorder.
* Daily use of narcotics.
D: Inclusion Criteria:

* Age: 40-85 years
* ACR criteria for OA including Kellgren-Lawrence radiographic OA grades II-IV
* VAS pain score \>5/10 within 48 hrs of the phone screen and visit 1 (Screening)
* Knee OA for a minimum of 12 months
* Need for daily pain medication to manage symptoms of OA

Exclusion Criteria:

* Currently taking MAO inhibitors or any centrally acting drug for analgesia
* Narrow angle glaucoma
* Uncontrolled hypertension
* Co-existing inflammatory arthritis, fibromyalgia or other chronic pain state
* If a female, pregnant, trying to become pregnant, or lactating
* Major depressive disorder
* Substantial alcohol use or history of significant liver disease
* Diabetes, type 1 or type 2
* Condition in which the Investigator believes would interfere with the subject's ability to comply with study instructions, or might confound the interpretation of the study results or put the subject at undue risk
* Standard MRI safety exclusions

Answer: D