• PDtrials - Parkinson's Disease Clinical Trials
• /Browse By Symptom
• /Study does not address symptoms

Official Study Title: SAM-e Treatment of Depression in Parkinson's Disease
Sponsor: National Institute of Health
Clinicaltrials.gov ID: NCT00070941
Study ID: 07-149

Summary

Depression is a common problem among people with Parkinson's disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD), with a prevalence of 30-60% according to some estimates, but its cause is currently unknown. The medications targeting symptoms specific to PD may not work for the same symptoms caused by depression, such as sleep abnormalities, fatigue, apathy and the loss of facial expression. Many existing drugs for depression have potentially significant side effects.  Side Effects Any undesired actions or effects of a drug or treatment. Negative or adverse effects may include such symptoms as headache, nausea and upset stomach. In some cases, side-effects may cause more severe medical problems. Others may have dangerous interactions with common PD medications. Possible adverse effects include cardiac abnormalities, sedation, urinary retention, movement disorders and the worsening of parkinsonian symptoms.

S-adenosyl-methionine (SAM) is available as a health food supplement here in the US, has been used as an antidepressant in Europe for many years and has been shown to be effective in two small studies. It is a quick acting antidepressant that seems to work as well as other antidepressants, and has few side effects. In a small pilot study of SAM with people who were previously treated with other antidepressants, ten out of thirteen had at least a 50% improvement using a standardized depression scale.

The participants in this study will be randomized into two groups during the 12 week blinded phase. All participants will start with the lower dose of medication. If there is no clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. improvement in the depression after six weeks, they will receive the higher dose of medication. Upon completing the blinded phase, all participants will enter a 12 week continuation phase where they will receive SAM daily, divided into two doses. The blinded phase and continuation phase add up to a total of 24 weeks for the entire study. There will be 60 participants randomized into each group, all 120 of whom will enter the continuation phase.

Study Phase

Phase 2/3
What is a study phase?

Symptoms Addressed: Non-movement Symptoms

Depression, Cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. Moods

Time Commitment

• Less than six months
• See Trial Summary.

Eligibility

• Minimum Age: 30
• Maximum Age: 90
• Gender(s) Accepted: Either

Inclusion Criteria

• Diagnosed with idiopathic  IdiopathicOf, relating to, or designating a disease having no known cause. Parkinson's disease as indicated by the presence of at least two of the following signs: resting tremor,  Resting TremorA tremor of a limb that increases when the limb is at rest. rigidity,  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. bradykinesia,  BradykinesiaSlowness of movement. postural reflex impairment.
• On stable anti-parkinson medication regimen, with no change in medications for one week prior to the Screening  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. Visit.
• Meet criteria for major depression.
• Have discontinued antidepressant or antipsychotic medications at least 3 days prior to the Screening Visit.
• Agree not to start other pharmacotherapy, psychotherapy or behavior therapy  TherapyAnother word for “treatment”. while participating in the trial.
• Ability to read and/or follow written and oral instructions presented in English (or Spanish once a translated consent has been approved).
• Sufficient cognitive ability to provide informed consent  Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial. before any study procedures.

Exclusion Criteria

• Women who are pregnant or lactating.
• Use of another investigational drug  Investigational DrugDrug that is being tested in clinical trials prior to receiving FDA approval for use on the open market or as a treatment for a particular condition. within three months of study start.
• Use of St. John's Wort or any other "natural" product known to have mood enhancing properties in the 30 days prior to Screening.
• Treatment with selegiline  SelegilineInhibitor that increases the amount of dopamine in the brain to help control the symptoms of Parkinson's in people who are taking levodopa and carbidopa in combination (Sinemet). Selegiline may help people with Parkinson's to decrease the dose of levodopa/carbidopa needed to control symptoms, stopping the effects of levodopa/carbidopa from wearing off between doses, and increasing the length of time that levodopa/carbidopa will continue to control symptoms. (or other monoamine oxidase inhibitor) within the prior 6 weeks.
• Abuse of anti-anxiety or sleep medications. Use of stable standard therapeutic doses of prescribed anti-anxiety or sleep medications is allowed.
• Inability to withdraw from any psychoactive drug being taken for 3 days prior to the time of screening.
• Psychotherapy initiated in the past six months
• Lifetime history of bipolar disorder, hypomania, mania, schizophrenia or other psychotic disorder.
• History of serious suicidal attempt in the last twelve months; presence of serious suicidal tendencies/potential.
• Current usage of dopamine  DopamineA "chemical messenger" that regulates movement by assisting in the effective communication (transmission) of electrochemical signals in the brain from one nerve cell (neuron) to another. As dopamine producing cells degenerate with advancing PD, they no longer produce enough to regulate neurons elsewhere in the brain, resulting in a loss of control of movements, leading to symptoms such as slowed movements, tremor, and rigidity. receptor antagonist (metoclopramide, haloperildol).
• Secondary parkinsonian symptoms due to drugs (including dopamine receptor antagonists), metabolic disorders, cerebrovascular disease, encephalitis, or other degenerative  DegenerativeGradual deterioration of organs and cells along with loss of function. diseases.
• Inability to read, follow instructions or complete questionnaires in the English language (or Spanish once a translated consent has been approved by the IRB)  IRBA committee of physicians, statisticians, researchers, community advocates, and others chosen by an institution to initially approve and periodically review research projects involving human participants. Federal law requires this to ensure protection of participants’ safety, rights and welfare. .
• Deep brain stimulation  Deep Brain Stimulation (DBS)Procedure in which a small, surgically implanted, battery-operated medical device delivers electrical stimulation, and "turns-off" brain regions that produce Parkinson’s symptoms. (DBS) surgery.
• A history of cardiac, hepatic (liver), renal (kidney), hematologic (blood/bone), respiratory, endocrine (hormonal/glandular), vascular (blood vessels), metabolic or other bodily problems that are clinically relevant.

Enrollment

Expected Enrollment: 100 (US)
Date Enrollment Began: Jul 2003
Date Enrollment Ends: Mar 2008
Last Updated Date: Jan 24 2008
Trial Post Date: Jan 24 2008
Website: http://clinicaltrials.gov/show/NCT00070941

Primary Contacts and Locations

New York

• Mubasher Naseer
  NYU
  naseem01@med.nyu.edu
  Phone: 212-263-4838
  550 1st Ave. Suite RR-311
  New York, NY 10016
  USA