Major Depressive DisorderPhase 2LLDOPANCT06626152
Measuring Psychomotor Response to L-DOPA Challenge As a Biomarker for Outcomes in Late-Life Depression: a Pilot Feasibility Trial
A Phase 2 study testing Apo-levocarb in people with Major Depressive Disorder, run by University of British Columbia at 1 site in Canada.
Trial summary
Background Adults over the age of 60 with symptoms of major depressive disorder are said to have late-life depression (LLD), a condition that usually decreases a person's quality of life and is associated with other risks like physical frailty and dementia. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Apo-levocarb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 15 Aug 2024to 30 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient persons capable of providing informed consent
- Minimum age of 60 years old
- MINI International Neuropsychiatric Interview diagnosis of major depressive disorder, based on DSM-5 criteria
- MADRS score of ≥15 (moderate/severe depression)
- On stable doses of psychotropic medication, including antidepressant medication, for at least 4 weeks
- Able to adhere to the intervention schedule
Who cannot join
- Current diagnosis of major neurocognitive disorder
- Current active psychosis
- Unstable medical illness, including clinical or laboratory evidence of uncompensated cardiovascular, endocrine, hematologic, hepatic, pulmonary (including bronchial asthma), or renal disease
- Diagnosis of narrow angle glaucoma
- Suspicious, undiagnosed skin lesions or a history of melanoma
- History of myocardial infarction
Show all 16Show fewer
- Atrial, nodal, or ventricular arrhythmias
- History of seizures or seizure disorder
- History of peptic ulcer disease
- History of allergy or other hypersensitivity to levodopa, carbidopa, or to any other ingredient in the formulation of Levocarb
- Active suicidal ideation
- Psychotropic medication initiation or dose change <4 weeks prior to enrolment
- Regular use of dopamine antagonist or benzodiazepines ≥2mg lorazepam equivalent per day
- Unable to complete neuropsychological testing in the English language
- Have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests)
- History of falls, with ≥1 fall per week during the past 4 weeks
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Nicholas J Ainsworth, MD, 6048069090, nainsworth@providencehealth.bc.ca
About this study
Background
Adults over the age of 60 with symptoms of major depressive disorder are said to have late-life depression (LLD), a condition that usually decreases a person's quality of life and is associated with other risks like physical frailty and dementia. A common feature of more severe LLD is psychomotor slowing, where a person's ability to think and move are impaired. For example, they might not be able to walk or process information as quickly, and they might have problems with their working memory.
Read more
Psychomotor slowing in LLD might be the result of a problem with the way a person's body produces or responds to the neurotransmitter dopamine. The drug Levodopa (L-DOPA), which can replace missing dopamine in the brain, has been used to treat to treat Parkinson's disease for many decades, and it might also affect psychomotor slowing in LLD.
Methods
In this study, participants are adults aged 60 years or older with moderate to severe major depression. Participants undergo the "L-DOPA challenge"-a 2-week period where they receive a dose of L-DOPA once a day for the first week and a dose of L-DOPA twice a day for the second week. Before and after a participant completes the L-DOPA challenge, the study team assesses their depressive symptoms and psychomotor function. After the L-DOPA challenge, if a participant still shows signs of moderate or severe depression, they receive an antidepressant for 12 weeks.
Aims
The first aim of this study is to test the feasibility of the L-DOPA challenge-that is, whether most of the 50 participants recruited for this study will complete the L-DOPA challenge. For example, participants might have to withdraw if they can't make the daily visits to the research site to receive their L-DOPA medication, if they can't tolerate the medication's side effects, or if their depressive symptoms get significantly worse. Our hypothesis is that 80% of the participants will complete the L-DOPA challenge.
The second aim of the study is to see if L-DOPA affects participants' depressive symptoms, processing speed, and working memory. Our hypothesis is that L-DOPA response, measured as an improvement in gait speed, is associated with a decrease in depressive symptoms and an increase in processing speed and working memory.
- Conditions
- Major Depressive Disorder
- Being tested
- Apo-levocarb
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apo-levocarbDrug
As above.
| Study group | Role | What they receive |
|---|---|---|
| L-DOPA Challenge | Experimental | 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. Receives: Drug: Apo-levocarb |
What is being measured
The primary outcome is the main question the study is designed to answer.
L-DOPA challenge completion rate
Number of participants who complete the 2-week challenge of receiving L-DOPA and post-challenge assessments
Measured: 6 months
Depressive symptoms
Change in depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale, after the L-DOPA challenge and after treatment for depression
Measured: At 2, 3, 7, and 15 weeks from baseline
Gait speed
Change in gait speed in response to L-DOPA, as measured by time to complete the 4-metre walk test.
Measured: At baseline and 2 weeks from baseline
Psychomotor speed
Changes in psychomotor speed in response to L-DOPA, as measured by the clinician-rated CORE instrument
Measured: At baseline and 2 weeks from baseline
Secondary outcomes (3)
Processing speed
Change in processing speed, as measured by the NIH Toolbox Cognitive Battery: Pattern Comparison tool, after the L-DOPA challenge and after treatment for depression
Measured: At 2 and 15 weeks from baseline
Working memory
Change in working memory, as measured by the NIH Toolbox Cognitive Battery: List Sorting tool, after the L-DOPA challenge and after treatment for depression
Measured: At 2 and 15 weeks from baseline
Side effects related to L-DOPA
Incidence, frequency, and severity of side effects following L-DOPA administration, related to the cardiovascular, respiratory, musculoskeletal, genitourinary, skin, and central nervous systems, as recorded on an Adverse Effects Monitoring Form
Measured: At 2 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start15 Aug 2024
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Health & Services
- Responsible party
- Principal investigator, Kevin Smith, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626152
- Sponsor's protocol ID
- LLDOPA
- Acronym
- LLDOPA
- Status last verified
- Oct 2024
- First submitted
- 3 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Psychomotor Response to L-DOPA Challenge As a Biomarker for Outcomes in Late-Life Depression: a Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT06626152
- Acronym / sponsor ID
- LLDOPA / LLDOPA
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Providence Health & Services
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background
Adults over the age of 60 with symptoms of major depressive disorder are said to have late-life depression (LLD), a condition that usually decreases a person's quality of life and is associated with other risks like physical frailty and dementia. A common feature of more severe LLD is psychomotor slowing, where a person's ability to think and move are impaired. For example, they might not be able to walk or process information as quickly, and they might have problems with their working memory.
Psychomotor slowing in LLD might be the result of a problem with the way a person's body produces or responds to the neurotransmitter dopamine. The drug Levodopa (L-DOPA), which can replace missing dopamine in the brain, has been used to treat to treat Parkinson's disease for many decades, and it might also affect psychomotor slowing in LLD.
Methods
In this study, participants are adults aged 60 years or older with moderate to severe major depression. Participants undergo the "L-DOPA challenge"-a 2-week period where they receive a dose of L-DOPA once a day for the first week and a dose of L-DOPA twice a day for the second week. Before and after a participant completes the L-DOPA challenge, the study team assesses their depressive symptoms and psychomotor function. After the L-DOPA challenge, if a participant still shows signs of moderate or severe depression, they receive an antidepressant for 12 weeks.
Aims
The first aim of this study is to test the feasibility of the L-DOPA challenge-that is, whether most of the 50 participants recruited for this study will complete the L-DOPA challenge. For example, participants might have to withdraw if they can't make the daily visits to the research site to receive their L-DOPA medication, if they can't tolerate the medication's side effects, or if their depressive symptoms get significantly worse. Our hypothesis is that 80% of the participants will complete the L-DOPA challenge.
The second aim of the study is to see if L-DOPA affects participants' depressive symptoms, processing speed, and working memory. Our hypothesis is that L-DOPA response, measured as an improvement in gait speed, is associated with a decrease in depressive symptoms and an increase in processing speed and working memory.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-DOPA Challenge | Experimental | Drug: Apo-levocarbParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Outpatient persons capable of providing informed consent
- Minimum age of 60 years old
- MINI International Neuropsychiatric Interview diagnosis of major depressive disorder, based on DSM-5 criteria
- MADRS score of ≥15 (moderate/severe depression)
- On stable doses of psychotropic medication, including antidepressant medication, for at least 4 weeks
Key exclusion criteria (16 listed)
- Current diagnosis of major neurocognitive disorder
- Current active psychosis
- Unstable medical illness, including clinical or laboratory evidence of uncompensated cardiovascular, endocrine, hematologic, hepatic, pulmonary (including bronchial asthma), or renal disease
- Diagnosis of narrow angle glaucoma
- Suspicious, undiagnosed skin lesions or a history of melanoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apo-levocarbAs above. | Drug | L-DOPA Challenge |
Primary outcome
L-DOPA challenge completion rate
Time frame: 6 months
Number of participants who complete the 2-week challenge of receiving L-DOPA and post-challenge assessments
Depressive symptoms
Time frame: At 2, 3, 7, and 15 weeks from baseline
Change in depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale, after the L-DOPA challenge and after treatment for depression
Gait speed
Time frame: At baseline and 2 weeks from baseline
Change in gait speed in response to L-DOPA, as measured by time to complete the 4-metre walk test.
Psychomotor speed
Time frame: At baseline and 2 weeks from baseline
Changes in psychomotor speed in response to L-DOPA, as measured by the clinician-rated CORE instrument
3 secondary outcomes
Processing speed
Time frame: At 2 and 15 weeks from baseline
Working memory
Time frame: At 2 and 15 weeks from baseline
Side effects related to L-DOPA
Time frame: At 2 weeks from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apo-levocarb in people with Major Depressive Disorder, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicholas J Ainsworth, MD (6048069090, nainsworth@providencehealth.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
L-DOPA challenge completion rate (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.