SAM-e for the Treatment of Depression in Patients With Parkinson's Disease
Information source: New York University School of Medicine
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease; Depression
Intervention: SAM-e (Drug); oral citalopram (Drug); placebo (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: New York University School of Medicine Official(s) and/or principal investigator(s): Alessandro Di Rocco, MD, Principal Investigator, Affiliation: NYU
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).
Clinical Details
Official title: SAM-e Treatment of Depression in Parkinson's Disease
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Change in Hamilton Depression Scale
Detailed description:
PD is commonly associated with depression, but conventional antidepressants have limited
efficacy in patients with PD and may exacerbate motor symptoms. SAM-e is available in the
United States as a food supplement and is promoted as a mood enhancer. SAM-e improves
dopamine transmission, may have a beneficial effect on dopamine receptors, and may be a good
alternative to the currently-used antidepressants in patients with PD. This study will
investigate whether SAM-e is safe and effective in the treatment of depression associated
with PD. The efficacy of SAM-e will be compared to placebo and to escitalopram, a selective
serotonin reuptake inhibitor commonly used for the treatment of depression in PD.
Participants in this study will be randomly assigned to receive SAM-e, escitalopram, or
placebo for 12 weeks. Some participants may choose to extend treatment for an additional 12
weeks (for a total of 24 weeks on study medication). Participants will have study visits at
entry and Weeks 2, 4, 8, and 12. Study visits will include neurological evaluation,
psychiatric evaluation, blood tests, and quality of life questionnaires. A telephone
interview will be conducted at Week 10.
Eligibility
Minimum age: 30 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
New York University, New York, New York 10003, United States
Additional Information
Starting date: July 2003
Last updated: January 17, 2013
|