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

NCT00070941 | Completed Phase 2 Results DMC

• 2 other identifiers: R01AT000941-01A1075255364
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Parkinson's Disease; Depression

Keywords

Parkinsons Disease; Depression; SAM-e

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Depression Scale

  very severe, \>23/29; severe, 19-22/29; moderate, 14-18/29; mild, 8-13/29; and no depression, 0-7/29 (Hamilton M., J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62.)

  12 weeks

Study Arms (3)

SAM-e

EXPERIMENTAL

40 subjects receiving oral SAM-e, 1200mg or 1800mg daily in two divided doses, and placebo escitalopram.

Drug: SAM-e

Escitalopram

ACTIVE COMPARATOR

40 subjects receiving oral escitalopram 20mg or 40 mg daily, in two divided doses, and placebo SAM-e.

Drug: oral escitalopram

Placebo Comparator

PLACEBO COMPARATOR

20 subjects receiving oral placebo escitalopram and placebo SAM-3 daily in two divided doses.

Drug: placebo

Interventions

SAM-e DRUG

oral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo escitalopram.

Also known as: 1 Experimental

SAM-e

oral escitalopram DRUG

20mg or 30mg daily in two divided doses, along with placebo SAM-e.

Escitalopram

placebo DRUG

oral placebo escitalopram and oral placebo SAM-e daily in two divided doses.

Placebo Comparator

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Office of Dietary Supplements (ODS): collaborator

Study Sites (1)

New York University

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Depression

Interventions

S-Adenosylmethionine; Escitalopram

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Propylamines; Amines; Nitriles; Benzofurans

Results Point of Contact

• Title: Dr. Alessandro Di Rocco
• Organization: NYU Parkinson and Movement Disorders Center

Alessandro.Dirocco@nyumc.org

212-263-4838

Study Officials

• Alessandro Di Rocco, MD

  NYU

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2003
• First Posted: October 13, 2003
• Study Start: July 1, 2003
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 13, 2016
• Results First Posted: July 13, 2016

Record last verified: 2016-06

Locations

US (1)