Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02513485 : Inflammation-related Alterations in Neurocircuitry: Reversal With Levodopa
PhasePhase 4
AgesMin: 18 Years Max: 65 Years
Eligibility
Inclusion Criteria:

- Subjects have signed a current version of the Informed Consent and HIPAA documents
prior to initiation of study procedures

- Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV major
depression and currently off antidepressant medication, unless otherwise approved by
the PI or PI's designee

- Hamilton Depression Rating Scale (HDRS) 17 > 20, unless otherwise approved by the PI,
or PI's designee

- Negative pregnancy test for women of childbearing potential

- Not breast feeding

Exclusion Criteria:

- Evidence of untreated or poorly controlled endocrine, cardiovascular, pulmonary,
hematological, renal, or neurological disease

- History of central nervous system (CNS) trauma or active seizure disorder requiring
medication unless otherwise approved by principal investigator, or PI's designee

- Current or history of migraines, glaucoma, melanoma, or bleeding disorder of any kind

- Autoimmune or inflammatory disorder of any kind

- Embedded metallic objects, prosthetics made of paramagnetic metals, aneurysmal clips
and/or a history of claustrophobia

- Chronic infection (e.g. hepatitis B or C or Human Immunodeficiency Virus infection)

- Chronic use of agents known to affect the immune system including glucocorticoid
therapy within the past 6 months, methotrexate within the past 1 year, chemotherapy of
any kind (past or present), immunotherapy of any kind (past or present), aspirin or
non-steroidal anti-inflammatory drugs (NSAIDs) (within the past 2 weeks), statins
(within the past 1 month), vaccinations (within the past 2 weeks), topical steroids
(within the past 2 weeks), and antibiotics (within the past two weeks) unless
otherwise approved by principal investigator or PI's designee.

- Suicide attempt within six months of screening, or active suicidal intent or plan, or
score >2 on Hamilton Depression Rating Scale (HDRS) Suicide Item, unless otherwise
approved by the PI or PI's designee

- A positive pregnancy test

- Organ transplants

- Current or history of cancer within the past five years besides basal cell carcinoma,
unless otherwise approved by the PI or PI's designee

- A score of <28 on the Mini Mental Status Exam (MMSE), unless otherwise approved by the
PI or PI's designee

- Wide Range Achievement Test (WRAT-3) score indicating less than 8th grade reading
level, unless otherwise approved by the PI or PI's designee

- History of the following: schizophrenia, schizoaffective disorder, other (non mood
disorder) psychosis, depression secondary to a medical condition, mental retardation,
dementia, or delirium

- Substance dependence [or abuse within the past year (except nicotine)], unless
otherwise approved by the PI or PI's designee

- Body Mass Index >40 to limit the impact of morbid obesity on the results, unless
otherwise approved by the principal investigator or PI's designee

- Active suicidal intent or plan and a score >2 on the Hamilton Depression Rating Scale
suicide item (item #3).

- Antisocial personality disorder diagnosis as assessed during clinical interview, as
well as a history of hospitalization and/or recurrent suicidal behavior judged to be
directly due to the personality disorder

- Current eating disorder (except binge eating related to depression) unless approved by
PI or PI's designee

- Any other condition which in the opinion of the investigator would make the patient
unsuitable for enrollment, or could interfere with participating in or completing the
protocol

- Smoking more than 1/2 pack a day or e-cig equivalent, unless approved by the PI or
PI's designee

- Initiation of any of the following medications, unless otherwise approved by the PI or
PI's designee: Aspirin or Aspirin-like compounds, Ibuprofen or Naproxen Sodium,
Cholesterol medications, Antibiotics, Herbal Medications, Psychiatric or Psychotropic
Medications, Omega-3 supplements, Topical Steroids, Vaccinations

- Currently on antidepressant medication, unless otherwise approved by the PI or PI's
designee
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02513485      |      Link to official Clinicaltrials.gov listing
Locations



Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2019 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740