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

Sponsors and Collaborators:	National Center for Complementary and Alternative Medicine (NCCAM) Office of Dietary Supplements (ODS)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00070941

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 II Phase III

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Depression Parkinson's Disease

Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	SAM-e Treatment of Depression in Parkinson's Disease

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

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

Estimated Enrollment:	80
Study Start Date:	July 2003
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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.
3: Placebo Comparator 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

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

Locations

United States, New York
New York University	Recruiting
New York, New York, United States, 10003
Contact: Alessandro DiRocco, MD alessandro.dirocco@med.nyu.edu
Principal Investigator: Alessandro Di Rocco, MD

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Office of Dietary Supplements (ODS)

Investigators

Principal Investigator:

Alessandro Di Rocco, MD

NYU

More Information

Responsible Party:	NYU School of Medicine ( Alessandro Di Rocco, MD Chief, Division of Movement Disorders, Department of Neurology )
Study ID Numbers:	R01 AT000941-01A1
Study First Received:	October 9, 2003
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00070941
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Parkinsons Disease
Depression
SAM-e

Study placed in the following topic categories:

Depression
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Depressive Disorder
Brain Diseases
Neurodegenerative Diseases
Citalopram

Serotonin
Behavioral Symptoms
Parkinson Disease
Mental Disorders
Movement Disorders
Mood Disorders
Parkinsonian Disorders
Dexetimide

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009