NCT04650217 is a Phase 4 clinical trial of Carbidopa/levodopa in Depressive Disorder, sponsored by New York State Psychiatric Institute.

Who is sponsoring NCT04650217?

NCT04650217 is sponsored by New York State Psychiatric Institute.

What drugs are being tested in NCT04650217?

Interventions in NCT04650217: Carbidopa/levodopa, Placebo, Exercise training, Control.

What condition does NCT04650217 study?

NCT04650217 studies Depressive Disorder.

Is NCT04650217 still recruiting?

NCT04650217 is currently terminated. Last updated 2 February 2023.

Are results published for NCT04650217?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-02-02 · How we verify

NCT04650217

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Levodopa and Exercise for Older Adults With Depression and Psychomotor Slowing

Terminated Phase 4 Results posted Last updated 2 February 2023

What this trial tests

Phase 4 trial testing Carbidopa/levodopa in Depressive Disorder in 1 participant. Terminated before completion.

Timeline

7 October 2021

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	New York State Psychiatric Institute
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1
Start date	7 October 2021
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across United States

Drugs / interventions tested

Carbidopa/levodopa
Placebo
Exercise training
Control

Conditions studied

Depressive Disorder — all drugs for Depressive Disorder →

Sponsor

New York State Psychiatric Institute

Who can join

Adults 60 to 100, any sex, with Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Montgomery Asberg Depression Rating Scale (MADRS) Primary · Week 0 (Baseline)

The MADRS is a standard rater-administered measure of depression severity that will be used to measure changes in depressive symptoms during the study. The total MADRS score ranges from a minimum score of 0 to a maximum score of 60. Higher scores indicate more severe depression.

Group	Value	95% CI
Non-randomized Participants	25

Sponsor's own description

In this new research study, 80 adults aged \> 60 years with a significant depressive disorder and slowed processing and/or gait speed will be randomized to receive levodopa (L-DOPA; which the Candidate has previously shown to increase psychomotor speed and decrease depressive symptoms in older adults), aerobic exercise (itself an effective antidepressant treatment as monotherapy), or their combination in a 2x2 design incorporating placebo and a stretching/toning control. Participants will be evaluated before and after this 12-week duration study across cognitive domains, psychiatric symptoms, gait kinematics and mobility, and task-based magnetic resonance imaging (MRI) focused on effort-based decision making and reward processing. Data from this study will contribute toward the development of improved treatment and prevention strategies to maximize the functioning and active healthspan of older adults with neuropsychiatric disorders.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Carbidopa/levodopa

Trials testing the same drug.

NCT04493320 — 1/2-Dopaminergic Dysfunction in Late-Life Depression (The D3 Study) · Phase 4 · terminated

Other recruiting trials for Depressive Disorder

Currently open trials in the same condition.

NCT07290153 — Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC · recruiting
NCT07100951 — Comparing Brief Psychoanalytic Couple Therapy and Emotionally Focused Therapy in Reducing Relationship Distress · NA · recruiting
NCT06890208 — Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave · recruiting
NCT06901739 — Therapeutic Potential of a Synbiotic to Improve Mental Health in Subjects With Obesity. · NA · recruiting
NCT06724666 — Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression · NA · recruiting

Other New York State Psychiatric Institute trials

Trials by the same sponsor.

NCT05416658 — Shared Decision Making for Antipsychotic Medications · NA · not yet recruiting
NCT07423546 — A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia · Phase 1, PHASE2 · not yet recruiting
NCT05339256 — Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual · Phase 2 · not yet recruiting
NCT05563948 — Repeated Administration of Cannabis Varying in THC and CBD · Phase 2 · suspended
NCT06977308 — A Multimodal Imaging Study of Dopamine in Early Psychosis · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04650217 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by New York State Psychiatric Institute
Last refreshed: 2 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04650217.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing