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Phase 3 N=29 Randomized Triple-blind Treatment

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

Parkinson's Disease · Depression

Enrolled (actual)
29
Serious AEs
13.8%
Results posted
Jul 2016
Primary outcome: Primary: Change in Hamilton Depression Scale — 17; 17.5; 20.7; 11.4 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
SAM-e (Drug); oral escitalopram (Drug); placebo (Drug)
Age
Adult, Older Adult · 30+ yrs
Sex
All
Sponsor
NYU Langone Health
Primary completion
Jun 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Hamilton Depression Scale
17; 17.5; 20.7; 11.4; 5.3; 16.2

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).

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00070941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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