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

Depression Clinical Trial

Official title:

SAM-e Treatment of Depression in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00070941
• Other study ID #: R01AT000941-01A1
• Secondary ID: R01AT000941-01A1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 9, 2003
• Last updated: January 17, 2013
• Start date: July 2003
• Est. completion date: October 2010

Study information

• Verified date: January 2013
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• SAM-e
oral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo citalopram.
• oral citalopram
20mg or 30mg daily in two divided doses, along with placebo SAM-e.
• placebo
oral placebo citalopram and oral placebo SAM-e daily in two divided doses.

Locations

Country	Name	City	State
United States	New York University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York University School of Medicine	National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hamilton Depression Scale		12 weeks	No