Reduction of Anticholinergic Medications for Mental Illness

(RAMP Trial)

Recruiting at 3 trial locations

Overseen By Professor of Psychiatry, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must be taking: Antipsychotics, Anticholinergics

Disqualifiers: Parkinsonian symptoms, Clinically unstable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

111 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce anticholinergic medications, which block certain nerve impulses, for individuals with serious mental illnesses such as schizophrenia or bipolar disorder. It focuses on those who no longer need these medications and are currently stable with their treatment. The trial suits individuals who have been on these medications for at least six months and are deemed stable by their healthcare providers. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance medication management for stable patients.

Do I have to stop taking my current medications for the trial?

The trial aims to reduce certain medications used for mental illness, so you may need to stop or reduce those specific medications. However, the protocol does not specify if you must stop all current medications. It's best to discuss with the trial team and your doctor.

What prior data suggests that reducing anticholinergic medications is safe for individuals with mental illness?

Research shows that reducing certain medications, known as anticholinergics, in individuals with mental illness might improve thinking and overall health. Long-term use of these medications can lead to memory and physical ability problems. Reducing their use may prevent or slow these issues.

Previous studies have not found a connection between these medications and serious conditions like dementia. While long-term use carries some risks, reducing them does not seem to introduce new safety concerns.

In summary, the aim is to reduce unnecessary medication to potentially enhance mental clarity and health. This approach appears safe based on current research, but each person's situation is unique. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the reduction of anticholinergic medications for mental illness because this approach aims to minimize side effects associated with these drugs. Most treatments for mental illness, like antipsychotics and antidepressants, can have significant anticholinergic side effects, such as memory issues and confusion. By reducing reliance on these medications, the goal is to improve overall cognitive function and quality of life for patients, without compromising the treatment of their mental health condition. This approach could lead to more personalized and tolerable treatment strategies.

What evidence suggests that reducing anticholinergic medication is effective for mental illness?

Research has shown that reducing certain medications, called anticholinergics, in people with psychosis or serious mental illness can lead to positive results. In this trial, participants will reduce their anticholinergic medications. One study found that patients who took fewer of these medications experienced fewer side effects. Another study showed that reducing these medications improved their ability to learn and remember words. Long-term use of anticholinergics has been linked to declines in physical and mental abilities, so reducing them might help prevent these problems. Overall, these findings suggest that taking fewer of these medications could improve mental functions and reduce unwanted side effects. ^{1 4 6 7 8}

Who Is on the Research Team?

Professor of Psychiatry, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals with conditions like schizophrenia, bipolar disorder, or other serious mental illnesses who are currently taking anticholinergic medications that may no longer be necessary.

Inclusion Criteria

Able and willing to sign the approved informed consent document

On an examination using the modified Simpson-Angus Extrapyramidal Symptoms Scale (head dropping and leg pendulousness items are dropped), no single item rated at 3 or 4

I am 18 years old or older.

Exclusion Criteria

My doctor agrees it's safe for me to join this trial.

If the clinicians treating the potentially eligible patients consider them to be clinically unstable or if drug-addiction is the focus of treatment and participation in ACM de-prescription protocols is considered risky, the team will defer to the treating clinicians to exclude participants

I need medication for Parkinson's symptoms due to side effects.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo anticholinergic medication reduction using a stepped-wedge, randomized trial design

16 weeks

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of cognitive and side effects

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Reduction of Anticholinergic Medication

Trial Overview The study aims to assess the effects of reducing anticholinergic medication in patients with psychiatric disorders. It will observe changes in cognitive functions and overall health after lowering these meds.

How Is the Trial Designed?

Group I: Anticholinergic Medication Reduction Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29178683/

Reducing Anticholinergic Medication Burden in Patients ... In this interdisciplinary, collaborative QI project, patients whose anticholinergic burden was reduced experienced a significant improvement in side effects ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07043803

Reduction of Anticholinergic Medications Among Persons ... In addition to affirming earlier positive clinical outcomes in the preliminary work, the investigators intend to assess barriers to and facilitators of ...

3. psychiatryonline.org psychiatryonline.org/ajp/doi/10.1176/appi.ajp.20240260

Anticholinergic Burden and Cognitive Function in Psychosis Finally, tapering off anticholinergic medication improved the scores in verbal learning (d=0.77, 95% CI=0.44, 1.1), working memory (d=0.94, 95% ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551741120312353

Deprescribing anticholinergic medication in the community ... Conclusions. These results suggest that deprescription of ACM in a community mental health center can occur with prescriber education and support. However, ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jir.70018

Ten‐Year Outcomes of Anticholinergic Use Among Older ... In the general population, the long-term exposure to anticholinergics has been associated with declines in both physical and cognitive function.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10704558/

Anticholinergic deprescribing interventions for reducing risk of ... Reducing anticholinergic burden through deprescribing interventions may help to prevent onset of cognitive impairment or slow the rate of cognitive decline.

7. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp.20250124

A Call to Psychiatrists: Deprescription of Unnecessary ... To this point, a recent study of 112,542 persons with mental illness reported that 54% had moderate to high anticholinergic medication burden, ...

8. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2020.00030/full

Are Anticholinergic Medications Associated With Increased ... In this study, the usage of anticholinergics was not associated with the risk of dementia or BPSD in a 15-year follow-up study.