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Dopaminergic Therapy

Dopaminergic Therapy for Depression with Anhedonia (DTA-2 Trial)

Phase 4

Recruiting

Led By Jennifer Felger, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Men or women, 25-55 years of age

Primary diagnosis of DSM-V MD, current, as diagnosed by the SCID-V

Must not have

History of a cognitive disorder or traumatic head injury involving loss of consciousness

Use of gender affirming hormone therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, weeks 1-4 post-intervention, weeks 5-8 post-intervention

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial studies a new treatment for depression with high inflammation and anhedonia. 70 people aged 25-55 will take an 8-week course of L-DOPA or placebo, and complete tests & scans. Participation length is 10-12 weeks.

Who is the study for?

This trial is for men and women aged 25-55 with depression, specifically those who experience a lack of pleasure (anhedonia) and have high inflammation levels. Participants must not be on antidepressants or other psychotropic drugs for at least 4 weeks, have a CRP level ≥2 mg/L, and score highly on specific depression scales. Pregnant individuals, those with certain medical conditions or medication intolerances, substance abuse issues, or positive drug tests are excluded.

What is being tested?

The DTA-2 study is testing the effectiveness of Carbidopa Levodopa (L-DOPA), a dopaminergic therapy against a placebo in treating anhedonia in depressed individuals over an 8-week period. The study involves random assignment to either the medication or placebo group and includes lab tests, assessments, tasks related to motivation and movement control as well as MRI scans.

What are the potential side effects?

While side effects are not explicitly listed here, Carbidopa Levodopa can typically cause nausea, dizziness upon standing up quickly (orthostatic hypotension), involuntary movements (dyskinesia), dry mouth among others. Placebo has no active ingredients but can lead to perceived side effects due to expectations.

Eligibility Criteria

Inclusion Criteria

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

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I am between 25 and 55 years old.

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I have been diagnosed with major depression.

Exclusion Criteria

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

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I have had a cognitive disorder or a head injury that caused me to lose consciousness.

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I am currently on hormone therapy for gender affirmation.

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I regularly use NSAIDs, glucocorticoids, or statins.

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I am not taking NSAIDs, glucocorticoids, or statins during the study.

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I have had cancer that needed treatment beyond minor surgery.

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I have a history of hepatitis B, C, or HIV.

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My heart, hormone, blood, liver, kidney, or nerve conditions are stable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, weeks 1-4 post-intervention, weeks 5-8 post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, weeks 1-4 post-intervention, weeks 5-8 post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 1-4 post-intervention, weeks 5-8 post-intervention for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in depressive symptom severity measured by Hamilton Depression Rating Scale (HAM-D)

Secondary study objectives

Change in Inventory of Depressive Symptomatology- Self-Report (IDS-SR)

Change in Motivation and Pleasure-Self-Report (MAP-SR)

Change in Snaith-Hamilton Pleasure Scale-Clinician (SHAPS-C)

+2 more

Side effects data

From 2023 Phase 4 trial • 19 Patients • NCT04723147

17%

Mild Nausea

17%

Headache

11%

Muscle pain (soreness)

11%

Insomnia

Back Pain

Paresthesia

Sinus Congestion

Dysuria

Irritability

Constipation

Mild Crawling skin sensation

Mild bruising of venipuncture

Heartburn

Mild Blurry vision when adjusting to glasses

Head Laceration

Chest tightness

Mild bruising on arm from workplace accident

Nausea and vomiting (Food poisoing)

100%

80%

60%

40%

20%

Study treatment Arm

Carbidopa Levodopa, 150 mg

Carbidopa Levodopa, 300 mg

Placebo

Carbidopa Levodopa 450 mg

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Carbidopa Levodopa GroupExperimental Treatment1 Intervention

Patients randomized to the Carbidopa Levodopa Group will receive one tablet per day of L-DOPA (150 mg levodopa administered with 37.5 mg carbidopa) for 4 weeks. Patients that respond after the initial 4 weeks will continue on the same dose for an additional 4 weeks to determine whether clinical response at the 150 mg dose is sustained over time compared to placebo. Patients that do not exhibit a clinical response (50% reduction in HAM-D scores from baseline) after 4-weeks on the 150 mg dose will escalate to 450 mg L-DOPA (three tablets per day of 150 mg levodopa administered with 37.5 mg carbidopa) and studied over an additional 4 weeks (8 weeks total in the study).

Group II: Placebo GroupPlacebo Group1 Intervention

Participants will receive placebo tablet. Placebo-treated non-responders at 4 weeks will remain on placebo but with the same instructions to increase daily pill intake.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carbidopa Levodopa

2021

Completed Phase 4

~40

0 / 9Eligibility criteria met