Please select the eligibility criteria that correspond to the clinical trial below.
Title: Brain Morphometries in OA Patients Treated With Duloxetine
Brief Summary: This study aims to determine in people with knee Osteoarthritis (OA) if relief of pain after treatment with either duloxetine or placebo is associated with changes in brain anatomy.


Options:
A: Inclusion Criteria:

* Age: 45-80 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, depression

* 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
* Use of MAO inhibitors, triptans, serotonin precursors (tryptophan)
* Use of potent CYP1A2 inhibitors, Thioridazine, and anti-depressants
* 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
* MRI safety necessitates the exclusion of subjects having one or more of the following:

  * Metal fragments in the eye or face, or having worked previously in the metal industry
  * Implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac, defibrillators, and cochlear implants or nerve stimulators.
  * Surgery on the blood vessels of the brain
  * Claustrophobia (fear of enclosed places)
  * Piercings or tattoos
  * More than 250 lbs in weight
  * Obvious brain abnormalities
B: Inclusion Criteria:

* primary knee osteoarthritis

Exclusion Criteria:

* inflammatory conditions
* autoimmune disorders
* psychiatric illness
* morbid obesity
C: DISEASE CHARACTERISTICS:

* Diagnosis of cancer

  * CNS malignancy allowed with the exception of leptomeningeal carcinomatosis
* Must have painful sensory chemotherapy-induced peripheral neuropathy (CIPN) resulting from prior treatment with single-agent taxane or platinum agents (paclitaxel, docetaxel, nab-paclitaxel, oxaliplatin, cisplatin) (may not have received drugs from both classes)

  * CIPN \> grade 1 as measured by NCI-CTCAE v 4.0
  * Average neuropathic pain score ≥ 4
* Patients with the following illnesses known to cause peripheral neuropathy are eligible, provided they have no evidence of neuropathy from these illnesses:

  * Diabetes mellitus
  * Peripheral vascular disease
  * HIV infection
  * Significant degenerative or familial neurologic disorder known to cause peripheral neuropathy
* No clinical or subclinical neuropathy from nerve compression injuries (i.e., carpal tunnel syndrome, brachial plexopathy, spinal stenosis, or spinal nerve root compression)

PATIENT CHARACTERISTICS:

* AST ≤ 3 times upper limit of normal
* Total bilirubin ≤ normal
* Creatinine clearance \> 30 mL/min
* Not pregnant or nursing
* Able to take oral or enteral medication
* No history of seizure disorder
* No diagnosis of ethanol addiction or dependence within the past 10 years
* No history of narrow-angle glaucoma
* None of the following:

  * History of suicidal thoughts
  * Symptoms of or history of schizophrenia, bipolar disease, or a major depression
  * Serious eating disorder such as bulimia or anorexia where electrolyte imbalance is likely

PRIOR CONCURRENT THERAPY:

* At least 3 months since prior and no concurrent taxane or platinum agent
* At least 14 days since prior and no concurrent monoamine oxidase inhibitors or other antidepressants
* No other prior or concurrent neurotoxic drugs (e.g., vincristine, vinblastine, cytarabine, thalidomide, bortezomib, carboplatin, or procarbazine)
* No concurrent anticonvulsants
* No concurrent B or E vitamin supplementation in doses greater than the recommended daily allowance (RDA)

  * Centrum (standard formula) and One-A-Day "essential" formula which contain 100% RDA for vitamins B6, E, and B12 allowed
  * Other multivitamins allowed provided they contain no more than 100% RDA of B vitamins and vitamin E
* No concurrent treatment (pharmacologic) for depression
D: Inclusion Criteria:

1. 18 years of age or above
2. Have a diagnosis of Diabetes mellitus for at least a year
3. Agree not to smoke whilst resident in the CRC
4. Able to understand the patient information sheet and provide written informed consent
5. Score above 12 on the LANSS
6. Have neuropathic pain of diabetic origin
7. Score above 25 on MMSE
8. Willing to withdraw, under the guidance of their diabetologist, from any current pain medication prior to their first visit to the sleep laboratory. Duration of withdrawal will be at least equivalent to 5 half-lives and will be of a relevant duration given the particular medication used.

Exclusion Criteria:

1. There is evidence of an end stage disease of a major system (hepatic, renal, respiratory, haematologic (PA), immunologic, cardiovascular, inflammatory, rheumatology, active infections, peripheral vascular disease, untreated endocrine(hypothyroid)
2. There is evidence of a recent ischaemic event
3. There is evidence of recurrent and/or severe hypoglycemia requiring assistance in last 3 years
4. Evidence of sleep pathology that would interfere with the assessment of treatment (assessed on habituation night)
5. Currently receiving treatment for malignancy
6. Suffer from seizures including epilepsy
7. There is evidence of a history of dependence on or abuse of alcohol/recreational drugs
8. Need to use a wheel chair (incompatible with studies in a sleep laboratory)
9. Involved in a clinical trial in last 3 months
10. Pregnant, lactating or inadequate contraception
11. Vision inadequate for the performance tests (as assessed at screening)
12. Colour Blind
13. Will not co-operate with study procedures
14. Will not give permission to inform GP

Answer: A