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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

DTA-2 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.Check my eligibility

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.See study design

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.

DTA-2 Trial 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.

DTA-2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

DTA-2 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

2018

Completed Phase 1

~20

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,587 Total Patients Enrolled

4 Trials studying Anhedonia

413 Patients Enrolled for Anhedonia

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,639 Total Patients Enrolled

17 Trials studying Anhedonia

1,806 Patients Enrolled for Anhedonia

Jennifer Felger, PhDPrincipal InvestigatorEmory University

3 Previous Clinical Trials

152 Total Patients Enrolled

2 Trials studying Anhedonia

95 Patients Enrolled for Anhedonia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation accept volunteers over the age of thirty?

"As per the study's admission requirements, participants must be between 25-55 years of age."

Answered by AI

Are there any possible risks associated with taking Carbidopa Levodopa Group?

"There is ample clinical evidence to suggest that Carbidopa Levodopa Group poses a minimal risk, thus its safety rating is set at 3."

Answered by AI

Is it feasible for me to enrol in this experiment?

"Qualifying participants must be aged 25-55 and experience anhedonia. 70 individuals are being admitted to the trial."

Answered by AI

Are there any vacancies for individuals to participate in this investigation?

"This clinical trial, initially posted on November 1st 2023 and last updated October 4th 2023 is no longer enrolling patients. However, there are 1393 other medical trials actively recruiting participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dopaminergic Therapy for Anhedonia - 2

Jennifer Felger 2023. "Dopaminergic Therapy for Anhedonia - 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06075771.