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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Parkinson's Disease, Depression

In brief

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

Key facts

Study ID

NCT00070941

Run by

NYU Langone Health

People needed

29

Starts

2003-07-01

Expected to finish

2010-10-01

Last updated by the study team

2016-07-13

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• New York University — New York, New York, United States

Full record on ClinicalTrials.gov

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