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

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Alessandro DiRocco, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00070941
First received: October 9, 2003
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Parkinson's Disease
Depression
Drug: SAM-e
Drug: oral citalopram
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: SAM-e Treatment of Depression in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Change in Hamilton Depression Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: July 2003
Study Completion Date: October 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
40 subjects receiving oral SAM-e, 1200mg or 1800mg daily in two divided doses, and placebo citalopram.
Drug: SAM-e
oral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo citalopram.
Active Comparator: 2
40 subjects receiving oral citalopram 20mg or 40 mg daily, in two divided doses, and placebo SAM-e.
Drug: oral citalopram
20mg or 30mg daily in two divided doses, along with placebo SAM-e.
Placebo Comparator: 3
20 subjects receiving oral placebo citalopram and placebo SAM-3 daily in two divided doses.
Drug: placebo
oral placebo citalopram and oral placebo SAM-e daily in two divided doses.

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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070941

Locations
United States, New York
New York University
New York, New York, United States, 10003
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Alessandro Di Rocco, MD NYU
  More Information

No publications provided

Responsible Party: Alessandro DiRocco, Neurologist, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00070941     History of Changes
Other Study ID Numbers: R01 AT000941-01A1, R01AT000941-01A1
Study First Received: October 9, 2003
Last Updated: January 17, 2013
Health Authority: United States: Federal Government

Keywords provided by New York University School of Medicine:
Parkinsons Disease
Depression
SAM-e

Additional relevant MeSH terms:
Depression
Depressive Disorder
Parkinson Disease
Basal Ganglia Diseases
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Mood Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2014