Methylphenidate Plus GWI-Nutrient Formula as a Treatment for Patients With Gulf War Illness
Status unconfirmed · Phase 2
Conditions studied: Gulf War Illness
In brief
The Gulf War Synergy Trial will evaluate the safety and efficacy of a currently available medication, methylphenidate (Ritalin®), combined with a GWI Nutrient Formula (K-PAX Synergy) to treat Gulf War Illness (GWI).
Key facts
- Study ID
- NCT02357030
- Run by
- K-PAX Pharmaceuticals, Inc.
- People needed
- 30
- Starts
- 2015-01-01
- Expected to finish
- 2016-05-01
- Last updated by the study team
- 2015-10-15
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Pregnancy or lactation
- Active substance or alcohol abuse and/or a history of prescription stimulant abuse
- Hospitalization within the past five years for any of the following:
- Active substance or alcohol abuse and/or a history of prescription stimulant abuse
- Major Depressive Disorder (MDD)
- Post Traumatic Stress Disorder (PTSD)
- Previous or current diagnosis of schizophrenia or bipolar disorder
- Currently taking any prescription medication to treat anxiety on a daily basis
- Use of any of the below medications more than 3 times per week within the past 3 months:
- MAO inhibitors
- Anti-psychotic medications
- Prescription stimulants (i.e. Provigil®, Nuvigil®, Adderall®, Ritalin®, or any other amphetamines)
- Coumarin anticoagulants (Coumadin®)
- Daily concurrent use of more than one antidepressant medication except if one of the two antidepressant medications are one of the following (unless specifically granted a waiver by the Medical Monitor):
- Amitriptyline ≤ 100 qhs
- Trazodone ≤ 100 qhs
- Doxepin ≤ 50 qhs
- Active medical conditions including:
- Glaucoma
- Diabetes mellitus
- Current stomach or duodenal ulcer
- Uncontrolled hypertension (blood pressure at screening of systolic >160 or diastolic >90)
- Heart disease (including a history of cardiac arrhythmia, cardiac ischemia, syndrome of Torsade de Pointes, myocardial infarction or cerebrovascular event)
- Motor tics or a diagnosis or family history of Tourette's syndrome
- Previous history of seizures
Where it is running
- Veterans Administration Palo Alto Health Care System (VAPAHCS) — Palo Alto, California, United States (enrolling)
Full record on ClinicalTrials.gov
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