Phase 3
N=29
SAM-e for the Treatment of Depression in Patients With Parkinson's Disease
Parkinson's Disease · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00070941 ↗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
| Outcome | Result | p-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
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.