{"protocolSection":{"identificationModule":{"nctId":"NCT00070941","orgStudyIdInfo":{"id":"R01AT000941-01A1","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01AT000941-01A1"},"secondaryIdInfos":[{"id":"R01AT000941-01A1","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01AT000941-01A1"},{"id":"075255364","type":"OTHER_GRANT","domain":"NIH"}],"organization":{"fullName":"NYU Langone Health","class":"OTHER"},"briefTitle":"SAM-e for the Treatment of Depression in Patients With Parkinson's Disease","officialTitle":"SAM-e Treatment of Depression in Parkinson's Disease."},"statusModule":{"statusVerifiedDate":"2016-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2003-07"},"primaryCompletionDateStruct":{"date":"2010-06","type":"ACTUAL"},"completionDateStruct":{"date":"2010-10","type":"ACTUAL"},"studyFirstSubmitDate":"2003-10-09","studyFirstSubmitQcDate":"2003-10-10","studyFirstPostDateStruct":{"date":"2003-10-13","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-05-03","resultsFirstSubmitQcDate":"2016-06-02","resultsFirstPostDateStruct":{"date":"2016-07-13","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-06-02","lastUpdatePostDateStruct":{"date":"2016-07-13","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"NYU Langone Health","class":"OTHER"},"collaborators":[{"name":"National Center for Complementary and Integrative Health (NCCIH)","class":"NIH"},{"name":"Office of Dietary Supplements (ODS)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study will test a chemical called s-adenosyl-methionine (SAM-e) for the treatment of depression in patients with Parkinson's disease (PD).","detailedDescription":"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.\n\nParticipants 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."},"conditionsModule":{"conditions":["Parkinson's Disease","Depression"],"keywords":["Parkinsons Disease","Depression","SAM-e"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"FACTORIAL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":29,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"SAM-e","type":"EXPERIMENTAL","description":"40 subjects receiving oral SAM-e, 1200mg or 1800mg daily in two divided doses, and placebo escitalopram.","interventionNames":["Drug: SAM-e"]},{"label":"Escitalopram","type":"ACTIVE_COMPARATOR","description":"40 subjects receiving oral escitalopram 20mg or 40 mg daily, in two divided doses, and placebo SAM-e.","interventionNames":["Drug: oral escitalopram"]},{"label":"Placebo Comparator","type":"PLACEBO_COMPARATOR","description":"20 subjects receiving oral placebo escitalopram and placebo SAM-3 daily in two divided doses.","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"SAM-e","description":"oral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo escitalopram.","armGroupLabels":["SAM-e"],"otherNames":["1 Experimental"]},{"type":"DRUG","name":"oral escitalopram","description":"20mg or 30mg daily in two divided doses, along with placebo SAM-e.","armGroupLabels":["Escitalopram"]},{"type":"DRUG","name":"placebo","description":"oral placebo escitalopram and oral placebo SAM-e daily in two divided doses.","armGroupLabels":["Placebo Comparator"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Hamilton Depression Scale","description":"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.)","timeFrame":"12 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria\n\n* 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\n* Stable anti-parkinson medication regimen, with no change in medications in the 4 weeks prior to study entry\n* No antidepressant or antipsychotic medications within 30 days prior to study entry\n* Agree not to start other pharmacotherapy, psychotherapy, or behavior therapy while participating in the trial\n* Acceptable methods of contraception\n* Ability to read and/or follow written and oral instructions presented in English\n* Sufficient cognitive ability (baseline Mini-Mental Status \\> 24) to provide informed consent\n\nExclusion Criteria\n\n* History of cardiac, hepatic, renal, hematologic, respiratory, endocrine, vascular, metabolic, or other systems abnormalities that are clinically relevant in the opinion of study officials\n* Certain abnormal laboratory values\n* Pregnant or breastfeeding\n* Use of an investigational drug within 3 months of study entry\n* 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\n* Selegiline or other monoamine oxidase inhibitor within the 6 weeks prior to study entry\n* Regular usage of anti-anxiety medications or habitual use of sleep medications, although occasional use of certain hypnotics (temazepam, melatonin, or zolpidem) is allowed\n* Psychotherapy initiated in the 6 months prior to study entry\n* History of bipolar disorder, hypomania, mania, schizophrenia, or other psychotic disorder\n* Serious suicidal attempt in the 12 months prior to study entry or serious suicidal tendencies/potential\n* Use of dopamine receptor antagonist (metoclopramide, haloperidol)\n* Secondary Parkinsonian symptoms due to drugs (including dopamine receptor antagonists), metabolic disorders, cerebrovascular disease, encephalitis, or other degenerative diseases","healthyVolunteers":false,"sex":"ALL","minimumAge":"30 Years","maximumAge":"80 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Alessandro Di Rocco, MD","affiliation":"NYU","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"New York University","city":"New York","state":"New York","zip":"10003","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"The recruitment dates 01NOV2006-31OCT2008 locations: James Godbold, PH.D. Mount Sinai School of Medicine Steven Ferrando, MD - Weill Medical College of Cornell University Teodoro Bottiglieri, Ph.D. - Baylor College of Medicine Dr. Peter Werner - Albert Einstein College of Medicine","groups":[{"id":"FG000","title":"SAM-e","description":"SAM-e, 1200mg or 2400 mg"},{"id":"FG001","title":"Escitalopram","description":"oral Escitalopram 10mg or 20m"},{"id":"FG002","title":"Placebo Comparator","description":"oral placebo Escitalopram and placebo SAM-e"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"6"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"NOT 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Report only those publications resulting directly from this grant and those publications. If there have been no publications, so state."},"pointOfContact":{"title":"Dr. Alessandro Di Rocco","organization":"NYU Parkinson and Movement Disorders Center","email":"Alessandro.Dirocco@nyumc.org","phone":"212-263-4838"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D010300","term":"Parkinson Disease"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D020734","term":"Parkinsonian Disorders"},{"id":"D001480","term":"Basal Ganglia Diseases"},{"id":"D001927","term":"Brain Diseases"},{"id":"D002493","term":"Central Nervous System Diseases"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D009069","term":"Movement Disorders"},{"id":"D000080874","term":"Synucleinopathies"},{"id":"D019636","term":"Neurodegenerative Diseases"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D012436","term":"S-Adenosylmethionine"},{"id":"D000089983","term":"Escitalopram"}],"ancestors":[{"id":"D008715","term":"Methionine"},{"id":"D000603","term":"Amino Acids, Sulfur"},{"id":"D013457","term":"Sulfur Compounds"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D000241","term":"Adenosine"},{"id":"D011684","term":"Purine Nucleosides"},{"id":"D011687","term":"Purines"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D000596","term":"Amino Acids"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D009705","term":"Nucleosides"},{"id":"D009706","term":"Nucleic Acids, Nucleotides, and Nucleosides"},{"id":"D012263","term":"Ribonucleosides"},{"id":"D011437","term":"Propylamines"},{"id":"D000588","term":"Amines"},{"id":"D009570","term":"Nitriles"},{"id":"D001572","term":"Benzofurans"}]}},"hasResults":true}