To participate in the Synergy trial you must meet the following criteria:

1. Be between the ages of 18-59

2. Qualify for a diagnosis of Chronic Fatigue Syndrome (CFS) – see "What is CFS"

3. Be willing to NOT take any nutritional or herbal supplements other than the study treatment during the 12- week course of the trial (see Study Treatment). The following exempted supplements may continue to be taken:

Probiotic supplements (L. acidophilus, Bifidobacterium, etc...)
Fiber supplements
Digestive enzymes
Melatonin < 10mg per day
Calcium < 600mg per day
Magnesium < 400mg per day
Vitamin D < 400 i.u. per day

4. Willingness to NOT consume caffeine-containing drinks or shots (such as Red Bull®, Rockstar®, Monster®, or 5-hour Energy Shots®) during the 12-week course of the trial (coffee, tea, or chocolate are permitted).

5. Willingness to NOT consume any pseudophedrine-containing products including over-the-counter cold formulas (such as Sudafed® or TheraFlu®) during the 12-week course of the trial.

6. Willingness to practice effective contraception.

There are several criteria that will exclude you from participating in this study:

1. If you are currently pregnant or breastfeeding.

2. If you are currently abusing alcohol or other drugs.

3. If you have current symptoms that qualify you for a diagnosis of Major Depressive Disorder.

4. If you have any of the following medical conditions:

Diabetes Mellitus
Current stomach or duodenal ulcer
Uncontrolled hypertension
Heart disease (including cardiac arrhythmia, cardiac ischemia, syndrome of Gilles de la Tourette or a past history of myocardial infarction [heart attack] or cerebrovascular event [stroke])
Motor tics or family history of or diagnosis of Tourette's Syndrome
Previous history of psychosis (schizophrenia) or bipolar disorder (manic depressive disorder)
A previous history of seizures
HIV infection
Chronic Hepatitis B or C infection
Cancer (receiving treatment currently or within the past two years)
Chronic Kidney Disease

5. If you have an abnormal Electrocardiogram (ECG) that is clinically significant

Medication Exclusions:

Aside from the above medical conditions, there are several medications that may not be taken while participating in the Synergy Trial.* If you have taken any of the following medications more than 3 times per week within the past 3 months, you are not eligible:
MAO inhibitors (i.e. Marplan®, Nardil®, Emsar®, Parnate®)
Anti-psychotic medications (i.e. Haldol®, Seroquel®, Zyprexa®, Abilify® )
CNS stimulants (i.e. Ephedrine®, Ritalin®, Modafinil®, Provigil®, Nuvigil®, Concerta®, Adderall®)
Narcotic Opioids (i.e. Oxycodone®, Fetanyl®, Codeine®)
Tramadol (i.e. Ultram®, Ultracet®, Conzip®, or Ryzolt®)
Gabepentin (Neurontin®) >600mg per day
Pregablin (Lyrica®)
Duloxetine (Cymbalta®)
Milnacipran (Savella®)
Coumarin anticoagulants (Coumadin®)
Valganciclovir (Valcyte®)
Any medication to treat anxiety on a daily basis (Valium®, Klonopin®, Ativan®, etc.). Taking these medication at night to promote sleep is allowed.
You may not have taken the medication rintatolimod (Ampligen®) at all within 3 months of the screening visit.

*Do not make any changes to your medications without prior approval by your regular physician. To qualify for the Synergy Trial, you also may not be taking more than 1 antidepressant medication per day unless the second antidepressant you are taking is being used to help promote sleep such as those included in the following list*:

Amitriptyline <30mg
Trazodone <50mg
Doxepin <20mg

*Do not make any changes to your medications without prior approval by your regular physician. After reviewing the above information, if you have any questions about your eligibility, or you would like to participate in the Synergy Trial, please call 1-855-318-HOPE (4673). Thank you!

Symptoms grading scale: 0: None  1: Mild  2: Moderate  3: Substantial  4: Severe  5: Very Severe