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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether citalopram can reduce the build-up of harmful plaques in the brains of people with Parkinson's disease. These plaques are believed to affect the ability to understand and interpret visual information. The study will compare the effects of citalopram to a placebo (a pill with no active drug) over 26 months. It seeks participants diagnosed with Parkinson's disease who experience issues with processing visual information. However, individuals currently on certain medications or with a history of depression treatment may not be eligible. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 there any evidence suggesting that citalopram is likely to be safe for humans?

Research has shown that citalopram, a medication for depression, has been studied for use in people with Parkinson's disease (PD). Some studies suggest it can reduce feelings of depression and anxiety in those with PD. However, reports indicate it might worsen movement problems for some individuals. While citalopram may improve mood, it might not be suitable for everyone with PD. This trial is in the early stages, so much remains to be learned about how people handle citalopram over time. Prospective participants should consult their doctor to understand the benefits and risks based on their situation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about citalopram for Parkinson's disease because it offers a novel approach compared to standard treatments like levodopa and dopamine agonists, which primarily focus on replenishing dopamine levels. Citalopram is a selective serotonin reuptake inhibitor (SSRI) typically used to treat depression, and its unique mechanism targets serotonin pathways, which may help alleviate some non-motor symptoms of Parkinson's, such as mood disturbances. This could potentially improve the overall quality of life for patients by addressing aspects of the disease that current therapies do not directly target.

What evidence suggests that citalopram might be an effective treatment for Parkinson's disease?

Research shows that citalopram might help people with Parkinson's disease, particularly by treating depression. Studies have found that citalopram can lessen depression symptoms and improve the quality of life for those with Parkinson's. In this trial, participants will receive either citalopram or a placebo to investigate whether citalopram can also affect the build-up of harmful brain plaques linked to thinking problems in Parkinson's. While no direct evidence yet exists regarding citalopram's effect on these plaques, its success in improving mood suggests it might also benefit brain function. ^{1 3 6 7 8}

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15377738/

Citalopram treatment of depression in Parkinson's disease This is the first study that provides data suggesting that treating depression in patients with PD may lead to improvements in anxiety and functional capacity.

2. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/jnp.16.3.315

Citalopram Treatment of Depression in Parkinson's Disease This is the first study that provides data suggesting that treating depression in patients with PD may lead to improvements in anxiety and functional capacity.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5992618/

Efficacy and tolerability of antidepressants in Parkinson's ... This review suggests that multiple antidepressant classes are potentially efficacious in the treatment of depression in PD.

4. ajmc.com ajmc.com/view/pramipexole-citalopram-effective-therapies-for-depression-in-parkinson-disease

Pramipexole, Citalopram Effective Therapies for ... Patients with Parkinson disease demonstrated significant reduction in depressive symptoms with citalopram and pramipexole, with pramipexole ...

5. journals.lww.com journals.lww.com/jrms/fulltext/2022/27000/comparison_of_pramipexole_and_citalopram_in_the.55.aspx

Comparison of pramipexole and citalopram in the treatment... The results indicated that both citalopram and pramipexole were effective in the alleviation of depression and improving the quality of life in PD patients; ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10699393/

Worsening of Parkinson's disease by citalopram We report the case of a patient with PD who experienced a worsening in the motor status soon after the addition of citalopram to her antiparkinsonian drug ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6607952/

A review of citalopram dose restrictions in the treatment of ... The citalopram 12-month data showed a 55% reduction (P < .001) in the HAM-D and a 42% reduction in the Geriatric Depression Scale compared to ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1353802099000504

Worsening of Parkinson's disease by citalopram We report the case of a patient with PD who experienced a worsening in the motor status soon after the addition of citalopram to her antiparkinsonian drug ...