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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00070941

NCT00070941
Completed Phase 3

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with Parkinson's disease and show at least two of these signs: shaking at rest, muscle stiffness, slowness of movement, or balance problems
  • Your Parkinson's medications have stayed the same for at least 4 weeks before joining the study
  • You have not taken any antidepressant or antipsychotic medications in the 30 days before joining
  • You agree not to start any new medications, talk therapy, or behavioral therapy while in the trial
  • You are using an acceptable form of birth control
  • You are able to read and/or follow instructions given in written or spoken English
  • You have enough mental clarity to understand and agree to take part (confirmed by a short memory and thinking test)

Who may not be able to join:

  • You have significant heart, liver, kidney, blood, breathing, hormone, blood vessel, or other serious health conditions that study doctors consider medically relevant
  • You have certain abnormal results on blood or lab tests
  • You are currently pregnant or breastfeeding
  • You have taken an experimental drug within the 3 months before joining
  • You have used St. John's Wort or any other natural supplement known to affect mood in the 30 days before joining
  • You have taken selegiline or a similar type of medication (called MAO inhibitors) within 6 weeks before joining
  • You regularly take anti-anxiety medications or routinely use sleep aids (occasional use of temazepam, melatonin, or zolpidem may be allowed — confirm with trial site)
  • You started any form of talk therapy or psychotherapy within the 6 months before joining
  • You have a history of bipolar disorder, mania, schizophrenia, or another psychotic condition
  • You have made a serious suicide attempt in the past 12 months, or are currently considered at serious risk of suicide
  • You are currently using certain medications that block dopamine (such as metoclopramide or haloperidol)
  • Your Parkinson's-like symptoms are caused by medications, a metabolic condition, stroke-related disease, brain infection, or another degenerative disease (rather than true Parkinson's disease)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
NYU Langone Health
Registry
clinicaltrials_gov
Start date
1 July 2003
Est. completion
1 June 2010

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Hamilton Depression Scale

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov