Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning
Condition: Brain Tumor
MeSH terms: Brain Neoplasms
Intervention: IR Methylphenidate; Modafinil; SR Methylphenidate
Intervention description: 10 mg by mouth (PO) twice daily x 4 Weeks; 200 mg PO Once Daily x 4 Weeks; 18 mg PO Once Daily x 4 Weeks
Intervention MeSH terms: Methylphenidate; Modafinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Brain Tumor; Methylphenidate; Ritalin; Modafinil; Provigil; Fatigue; Concentration

Summary:

      Primary Objective:

        -  To assess the efficacy of immediate release methylphenidate, sustained release
           methylphenidate, and the novel vigilance enhancing drug modafinil for the improvement of
           cognitive functioning in patients with brain tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient diagnosed with a brain tumor, either primary or metastatic

          2. Patient had prior radiation treatment to the brain

          3. Patient is > or = 18 years of age

          4. Patient has a Karnofsky performance status (KPS) performance of 70 at baseline

          5. Patient is using acceptable birth control methods. Female participants (if of child
             bearing age and sexually active) and male participants (if sexually active with a
             partner of child-bearing potential) must use medically acceptable methods of birth
             control, including abstinence, birth control pills, diaphragm with spermicide, condom
             with foam or spermicide, vaginal spermicidal suppository or surgical sterilization.

          6. Patient must speak and understand English or Spanish

          7. Patient has reported cognitive decline and is being considered for stimulant therapy
             by their neurologist

          8. Patient has provided written informed consent to participate in the study prior to
             enrollment to the study

        Exclusion Criteria:

          1. History of hypersensitivity reaction to methylphenidate or modafinil

          2. History of severe headaches, glaucoma, major psychiatric diagnosis, narcolepsy,
             Tourette's syndrome, marked anxiety, tension or agitation

          3. History of clinically significant pulmonary or cardiac disease

          4. Uncontrolled hypertension: has not been on a stable treatment dose for the past month,
             or has a systolic pressure consistently greater than 140 mm Hg or diastolic pressure
             consistently greater than 90 mm Hg

          5. Patients with uncontrolled seizures will be excluded

          6. Current use of illicit drugs or history of alcohol or drug abuse and/or abuse
             potential

          7. Moderate to severe depression (> 20 on Beck Depression Inventory II)

          8. If taking antidepressants, patient must be on a stable dose

          9. Currently taking psychostimulants, Monoamine oxidase (MAO) inhibitors, or
             anticoagulants

         10. Current use of the following herbals or supplements for fatigue relief
             (dehydroepiandrosterone (DHEA), S-Adenosyl methionine (SAME), ginkgo, ginseng, St.
             John's Wort)

         11. Any coexisting medical condition or are taking any concomitant medication that is
             likely to interfere with the safe administration of methylphenidate. Any potential
             interactions or coexisting medical condition not specified by the protocol will be
             determined by the prescribing physician as being exclusionary or not.

         12. Patients currently taking any erythropoietin type drugs