RECRUITING

Dopaminergic Therapy for Anhedonia - 2

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this 8-week, double-blind, placebo-controlled, study is to explore new treatment options for people with depression who have high inflammation and anhedonia. Seventy male and female participants with depression, between 25-55 years of age, with higher levels of inflammation and anhedonia will be randomized to receive L-DOPA or matched placebo over 8 weeks. Participants will complete lab tests, medical and psychiatric assessments, motivation and motor tasks, and MRI scans as part of the study. The total length of participation is approximately 10 to 12 weeks.

Official Title

Dopaminergic Therapy for Inflammation-Related Anhedonia in Depression - 2

Quick Facts

Study Start:2023-11-21

Study Completion:2027-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06075771

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* a. willing and able to give written informed consent * b. men or women, 25-55 years of age * c. a primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), current, as diagnosed by the Structured Clinical Interview for DSM-5 * d. score of \>10 on the Patient Health Questionnaire-9 (PHQ-9) or HAM-D score ≥18 * e. off all antidepressant or other psychotropic therapy (e.g. mood stabilizers, antipsychotics, anxiolytics, and sedative hypnotics) for at least 4 weeks prior to baseline visit (8 weeks for fluoxetine) * f. c-reactive protein (CRP) ≥2 mg/L * g. PHQ-9 anhedonia score ≥2	* a. history or evidence (clinical or laboratory) of an autoimmune disorder * b. history or evidence (clinical or laboratory) of hepatitis B or C infection or human immunodeficiency virus infection * c. history of any type of cancer requiring treatment with more than minor surgery * d. unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease (as determined by physical examination, EKG and laboratory testing) * e. history of any (non-mood-related) psychotic disorder; active psychotic symptoms of any type; history or current bipolar disorder; history or current gambling disorder; substance abuse/dependence within 6 months of study entry (as determined by standardized clinician interview) * f. active suicidal plan as determined by a score \>3 on item #3 on the HAM-D * g. an active eating disorder (except for patients with binge eating disorder in whom binging is clearly associated with worsening of mood symptoms) * h. a history of a cognitive disorder or traumatic head injury involving loss of consciousness * i. pregnancy or lactation * j. use of gender affirming hormone therapy * k. chronic use of non-steroidal anti-inflammatory agents (NSAIDS) (excluding 81mg of aspirin), glucocorticoid containing medications or statins * l. use of NSAIDS, glucocorticoids, or statins at any time during the study * m. urine toxicology screen is positive for drugs of abuse, n. any contraindication for MRI scanning * o. intolerance, sensitivity or contraindication to carbidopa-levodopa (including history of narrow-angle glaucoma, melanoma, gastric and/or duodenal ulcers, bleeding disorders, or frequent migraines)

Inclusion Criteria

Exclusion Criteria

* a. willing and able to give written informed consent
* b. men or women, 25-55 years of age
* c. a primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), current, as diagnosed by the Structured Clinical Interview for DSM-5
* d. score of \>10 on the Patient Health Questionnaire-9 (PHQ-9) or HAM-D score ≥18
* e. off all antidepressant or other psychotropic therapy (e.g. mood stabilizers, antipsychotics, anxiolytics, and sedative hypnotics) for at least 4 weeks prior to baseline visit (8 weeks for fluoxetine)
* f. c-reactive protein (CRP) ≥2 mg/L
* g. PHQ-9 anhedonia score ≥2

* a. history or evidence (clinical or laboratory) of an autoimmune disorder
* b. history or evidence (clinical or laboratory) of hepatitis B or C infection or human immunodeficiency virus infection
* c. history of any type of cancer requiring treatment with more than minor surgery
* d. unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease (as determined by physical examination, EKG and laboratory testing)
* e. history of any (non-mood-related) psychotic disorder; active psychotic symptoms of any type; history or current bipolar disorder; history or current gambling disorder; substance abuse/dependence within 6 months of study entry (as determined by standardized clinician interview)
* f. active suicidal plan as determined by a score \>3 on item #3 on the HAM-D
* g. an active eating disorder (except for patients with binge eating disorder in whom binging is clearly associated with worsening of mood symptoms)
* h. a history of a cognitive disorder or traumatic head injury involving loss of consciousness
* i. pregnancy or lactation
* j. use of gender affirming hormone therapy
* k. chronic use of non-steroidal anti-inflammatory agents (NSAIDS) (excluding 81mg of aspirin), glucocorticoid containing medications or statins
* l. use of NSAIDS, glucocorticoids, or statins at any time during the study
* m. urine toxicology screen is positive for drugs of abuse, n. any contraindication for MRI scanning
* o. intolerance, sensitivity or contraindication to carbidopa-levodopa (including history of narrow-angle glaucoma, melanoma, gastric and/or duodenal ulcers, bleeding disorders, or frequent migraines)

Contacts and Locations

Study Contact

Jennifer Felger, PhD

CONTACT

4047273987

jfelger@emory.edu

Principal Investigator

Jennifer Felger, PhD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory University Hospital

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Emory University

Jennifer Felger, PhD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-21

Study Completion Date2027-01

Study Record Updates

Study Start Date2023-11-21

Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

Anhedonia
Depression

Additional Relevant MeSH Terms

Anhedonia
Depression