Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia
Brief Summary: Fibromyalgia is a condition of chronic widespread pain, sleep disturbance and fatigue. Most of the patients with fibromyalgia complain of either non-restorative sleep or complaints of disturbed sleep due to pain. The study aimed at examining the effects of milnacipran on sleep disturbance in patients with fibromyalgia. The study is a randomized, double-blind, placebo controlled, two way crossover polysomnography (PSG) study to explore the effects of milnacipran on sleep disturbance. Patients received either milnacipran 50 mg twice a day (BID) or matching placebo.


Options:
A: Inclusion Criteria:

1. Men or women at least 18 years or older
2. Diagnosis of fibromyalgia
3. Clinically significant sleep disturbance, defined as difficulty in maintaining sleep (wake after sleep onset and arousal index) at least three times per week for at least one month
4. Understand and willing to cooperate with the study procedures
5. Maintain a normal sleep schedule, with daytime-awake and nighttime-sleep schedule, with customary bedtime between 9 PM and midnight, and rise time 5 AM and 9 AM
6. Patients who are able to speak, read, and understand English language and able to follow the study protocol, and are able to sign the informed consent

Exclusion Criteria:

1. Subject has any of the following medical conditions:

   Liver disease, blood disorder, autoimmune disease, endocrine, cardiovascular, hypertension, renal, hepatic, gastrointestinal, or neurological disorder, active peptic ulcer or inflammatory bowel disease
2. Significant sleep apnea
3. Periodic leg movement disorder (PLMD) or restless legs syndrome (RLS)
4. Any form of severe psychiatric illness, moderate to severe depression, including significant risk of suicide
5. Patients with uncontrolled glaucoma
6. Inability to discontinue the prohibited medications
7. Female of childbearing potential not using birth control measures; or lactating.
8. History of alcohol, narcotic, benzodiazepines or other substance abuse within the past one year.
9. Patient on prohibited medication will include but not limited to:

   * Anxiolytics, anti-convulsants, antipsychotics, lithium, barbiturates, anti-histamines, monoamine oxidase inhibitors, or medications that affect sleep
   * Any prescription or over the counter stimulants
   * Medications that are contraindicated with the use of milnacipran
10. Excessive caffeine use, defined as a consumption of more than 500 mg of caffeine or other xanthines, smoking \>1/2 a pack/day or alcohol use \>14 units/week
11. History of allergy to milnacipran.
B: 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
C: Inclusion Criteria:

* aged 21-64 years old
* insomnia complaint of at least one month duration that meets the Research Diagnostic Criteria for Insomnia
* meet DSM-IV criteria for a Major Depressive Episode (without psychotic features) as verified by the mood module of the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID

Exclusion Criteria:

* need immediate psychiatric (e.g., imminently suicidal patients) or medical care (e.g., patients with acute cardiac symptoms), or have attempted suicide in the past 6 months
* have a sleep-disruptive comorbid medical condition (e.g., moderate to severe rheumatoid arthritis
* are pregnant, trying to get pregnant, or not currently practicing adequate birth control methods
* score \< 27 on the Mini-Mental Status Exam
* meet DSM-IV criteria for Obsessive-Compulsive disorder, Generalized Anxiety Disorder, Post-Traumatic Stress Disorder, Acute Stress Disorder, Panic Disorder, Bipolar Disorder, Schizophrenia or any other psychotic disorders on the basis of a SCID interview
* meet DSM-IV criteria for Antisocial Personality Disorder or Borderline Personality Disorder on the basis of a SCID II interview schedule
* report frequent travel across time zones or work rotating or night shifts
* meet criteria for sleep apnea, restless legs syndrome or Circadian Rhythm Sleep Disorder on the basis of the Duke Structured Interview of Sleep Disorders (DSISD)
* have an apnea-hypopnea index \> 15 or periodic limb movement-related arousal index \> 15 per hour of sleep during a screening laboratory polysomnogram
* have a history of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence in the 6 months prior to screening or have a positive urine drug or alcohol test at the time of screening
* report having taken the study drug (escitalopram) for 28 days or more and then discontinuing the medication due to side effects or adverse event
* have a disorder characterized by altered metabolism, a seizure disorder, severe renal impairment, a history of upper gastrointestinal bleed disorder, or a history of a condition that could interfere with the absorption, distribution, metabolism, or excretion of escitalopram
* participated in any other investigational drug study within 30 days prior to screening or become enrolled in another such study during the time they are enrolled in the current project
* use of any drugs known or suspected to affect hepatic or renal clearance within 30 days prior to screening for the current project
* are taking any medications that interact with escitalopram (e.g., Cimetidine, Lithium, Sumatriptan, Carbamazepine, or Ketoconazole) and are not willing to both taper off such medications during a time period equal to more than five half lives before entering the study and abstain from such medications throughout the study
* are unwilling or unable to abstain from non-study prescription medications for sleep (e.g., sedative hypnotics) or depression during their time in the study
* are known to be seropositive for Human Immunodeficiency Virus (HIV).
D: Inclusion Criteria:

* Completed an alcohol detoxification program.
* Meets criteria for alcohol dependence.
* Meets criteria for sleep disturbance.
* If female of childbearing potential must be using adequate contraception.
* Has a location to which they will return after the initial research interview and a person they regularly contact.
* Speaks English sufficiently to understand instructions and assessment.

Exclusion Criteria:

* Meets criteria for substance dependence for sedative/hypnotic drugs, stimulants, cocaine or opiates, or of organic brain disorder, bipolar disorder, schizophrenia, schizoaffective, schizophreniform, or paranoid disorder, or major depression.
* Current suicidality.
* Use of psychotropic, antidepressant, anxiolytic or antidipsogenic medication.
* Inability or refusal to terminate the use of proerectile agents, herbal medications or sleep medication for the study period.
* The presence of contraindications to the study medications, including pregnancy/lactation, ischemic heart disease, cardiac arrhythmias, priapism or hypotension.
* Presence of comorbid medical conditions associated with sleep disturbance including obstructive sleep apnea, poorly controlled diabetes mellitus or emphysema.
* Evidence of neuropsychological dysfunction.
* Probation/parole requirements that might interfere with participation in study.
* Inability to identify at least one contact person.
* Living on the street after detoxification (homeless persons living in a shelter, halfway house or other residence will not be excluded).

Answer: A