Citalopram for Parkinson's Disease

Overseen By Cate Lewis

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan

Must not be taking: Neuroleptics, Antidepressants

Disqualifiers: Atypical parkinsonism, Stroke, Depression, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 months

58 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial will test if taking citalopram for a long period can reduce harmful brain plaques in older adults with Parkinson's disease. The goal is to see if this can help prevent or slow down memory and thinking problems. The study involves patients aged 65 and older who do not have depression. Citalopram has been observed to improve motor performance in Parkinson's disease patients when combined with levodopa.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you've used antidepressants or certain other medications in the past year. It's best to discuss your specific medications with the trial team.

Is citalopram safe for use in humans?

Citalopram is generally considered safe for use in adults with depression, with common side effects like nausea, dry mouth, and increased sweating being mild to moderate. However, there is a report of citalopram potentially worsening motor symptoms in a Parkinson's disease patient, suggesting caution in this specific condition. ^{1 2 3 4 5}

How does the drug citalopram differ from other treatments for Parkinson's disease?

Citalopram, a selective serotonin reuptake inhibitor (SSRI), is unique in its potential to improve bradykinesia (slowness of movement) in Parkinson's disease patients, especially those also experiencing depression. Unlike some other treatments, it may help manage both motor and mood symptoms without worsening motor performance, although its impact on L-DOPA-induced dyskinesia (involuntary movements) is still under investigation. ^{2 3 6 7 8}

Is the drug citalopram effective for treating Parkinson's disease?

Citalopram, a drug used to treat depression, has shown mixed results in Parkinson's disease. While one study found it improved movement issues like bradykinesia (slowness of movement), another case report suggested it might worsen motor symptoms. Overall, it seems to help with depression without significantly affecting Parkinson's symptoms. ^{2 3 6 7 9}

Who Is on the Research Team?

Vikas Kotagal, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for people aged 65 or older with Parkinson's Disease, having specific disease severity scores (HY 2.0 to 3.0). They must not have used antidepressants in the past year, have no major brain damage on imaging, no life-threatening illnesses, and cannot be pregnant or breastfeeding.

Inclusion Criteria

I have been diagnosed with Parkinson's Disease.

I am 65 years old or older.

My Parkinson's disease is at a moderate stage.

Exclusion Criteria

You are currently participating in another research study.

Pregnancy or breastfeeding

Your heart's electrical activity, measured on a test called an EKG, is too long.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive citalopram 20mg daily or placebo for 26 months

26 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Citalopram
• Placebo

Trial Overview The study tests if Citalopram can slow down the build-up of harmful plaques in a part of the brain affecting vision-related cognition in Parkinson's patients over a period of 26 months compared to a placebo.

How Is the Trial Designed?

Group I: Citalopram Experimental Treatment 1 Intervention

20mg daily

Group II: Placebo Placebo Group 1 Intervention

matching placebo pills

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Citalopram, a selective serotonin reuptake inhibitor (SSRI), is considered safe for treating depression in adults, including the elderly and those with mild to moderate kidney and liver issues, based on data from clinical trials and published studies.

Common side effects like nausea and dry mouth are mostly mild and transient, and citalopram does not significantly increase the risk of serious issues such as suicide or heart problems, making it comparable in safety to other SSRIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of the safety of citalopram. Nemeroff, CB.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Worsening of Parkinson's disease by citalopram. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

SSRIs do not worsen Parkinson's disease: evidence from an open-label, prospective study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of serotonin transporter blockade on L-DOPA-induced dyskinesia in animal models of Parkinson's disease. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Remarkable effect of milnacipran, a serotonin-noradrenalin reuptake inhibitor (SNRI), on depressive symptoms in patients with Parkinson's disease who have insufficient response to selective serotonin reuptake inhibitors (SSRIs): two case reports. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The SSRI, citalopram, improves bradykinesia in patients with Parkinson's disease treated with L-dopa. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Sertraline for the treatment of depression in Parkinson's disease. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Overview of the safety of citalopram. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The safety and tolerability of citalopram. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of citalopram, a specific serotonin uptake inhibitor, in tardive dyskinesia and parkinsonism. [2019]