SAM-e for the Treatment of Depression in Patients With Parkinson's Disease

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will test a chemical called s-adenosyl-methionine (SAM-e) for the treatment of depression in patients with Parkinson's disease (PD).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); Office of Dietary Supplements (ODS)
• Treatments: Citalopram; Dexetimide

Criteria

Inclusion Criteria

• Idiopathic Parkinson's disease as indicated by the presence of at least two of the following signs: resting tremor, rigidity, bradykinesia, or postural reflex impairment

• Stable anti-parkinson medication regimen, with no change in medications in the 4 weeks prior to study entry

• No antidepressant or antipsychotic medications within 30 days prior to study entry

• Agree not to start other pharmacotherapy, psychotherapy, or behavior therapy while participating in the trial

• Acceptable methods of contraception

• Ability to read and/or follow written and oral instructions presented in English

• Sufficient cognitive ability (baseline Mini-Mental Status > 24) to provide informed consent

Exclusion Criteria

• History of cardiac, hepatic, renal, hematologic, respiratory, endocrine, vascular, metabolic, or other systems abnormalities that are clinically relevant in the opinion of study officials

• Certain abnormal laboratory values

• Pregnant or breastfeeding

• Use of an investigational drug within 3 months of study entry

• Use of St. John's Wort or any other "natural" product known to have mood enhancing properties in the 30 days prior to study entry

• Selegiline or other monoamine oxidase inhibitor within the 6 weeks prior to study entry

• Regular usage of anti-anxiety medications or habitual use of sleep medications, although occasional use of certain hypnotics (temazepam, melatonin, or zolpidem) is allowed

• Psychotherapy initiated in the 6 months prior to study entry

• History of bipolar disorder, hypomania, mania, schizophrenia, or other psychotic disorder

• Serious suicidal attempt in the 12 months prior to study entry or serious suicidal tendencies/potential

• Use of dopamine receptor antagonist (metoclopramide, haloperidol)

• Secondary Parkinsonian symptoms due to drugs (including dopamine receptor antagonists), metabolic disorders, cerebrovascular disease, encephalitis, or other degenerative diseases