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Dopamine Replacement Therapy

Levodopa for Depression (LLDOPA Trial)

Phase 2

Recruiting

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Minimum age of 60 years old

Be older than 18 years old

Must not have

History of peptic ulcer disease

History of falls, with ≥1 fall per week during the past 4 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effects of the drug Levodopa (L-DOPA) on late-life depression in adults over 60. Participants will undergo a 2-week L-DOPA

Who is the study for?

This trial is for adults over 60 with moderate to severe major depression, known as late-life depression (LLD). They must be able to visit the research site daily and tolerate L-DOPA's side effects. The study excludes those who cannot commit to the schedule or have conditions that may worsen with L-DOPA.

What is being tested?

The trial tests if Levodopa (L-DOPA) can improve psychomotor function in people with LLD by giving them a dose once daily for one week, then twice daily for another week. It also looks at whether this treatment affects depressive symptoms, processing speed, and working memory.

What are the potential side effects?

Possible side effects of L-DOPA include nausea, dizziness, headache, dry mouth, changes in blood pressure and heart rate. Some individuals might experience worsening of depressive symptoms or other mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had peptic ulcers in the past.

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I have fallen at least once a week in the last month.

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I have suspicious skin marks or a history of skin cancer.

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I have a heart rhythm problem.

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I have been diagnosed with a significant memory or thinking problem.

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I do not have any uncontrolled health conditions.

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I have been diagnosed with narrow angle glaucoma.

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I am currently experiencing thoughts of harming myself.

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I have had a heart attack before.

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I have a history of seizures.

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I regularly take medication like dopamine blockers or benzodiazepines at a dose equal to or more than 2mg of lorazepam daily.

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I cannot complete brain function tests in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Depressive symptoms

Gait speed

L-DOPA challenge completion rate

+1 more

Secondary study objectives

Processing speed

Side effects related to L-DOPA

Working memory

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: L-DOPA ChallengeExperimental Treatment1 Intervention

Participants will be administered a levodopa-carbidopa challenge, at a dosage of 150mg/37.5mg once daily for one week, followed by twice daily for one week. Psychomotor speed will be assessed before and after the challenge.

0 / 13Eligibility criteria met