Dopaminergic Therapy for Anhedonia - 2
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age25-55
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Carbidopa Levodopa
DrugPatients will receive between one and three tablets per day of 150 mg L-DOPA (administered with 37.5 mg carbidopa) to achieve doses ranging from 150 to 450 mg/day.
Placebo
DrugA placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive between one and three placebo tablets per day matching the Carbidopa Levodopa tablet.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Carbidopa Levodopa GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in depressive symptom severity measured by Hamilton Depression Rating Scale (HAM-D)
The HAM-D-17 is a 17-item, clinician administered scale, that rates severity of depression. Each item is rated on a scale 0-4 with higher scores indicating greater pathology.
Time frame
Baseline, weeks 1-4 post-intervention, weeks 5-8 post-interventionSecondary outcomes
1
Change in corticostriatal functional connectivity (FC) in reward circuits
Patients will undergo resting-state and task-based functional magnetic resonance imaging (fMRI) to calculate functional connectivity (FC) between the ventral striatum (VS) and ventromedial prefrontal cortex (vmPFC). FC is measured as continuous Z scores reflecting the correlation of activity between the brain regions. Higher FC Z scores reflect stronger connectivity.
Time frame
Baseline, week 4 post-intervention, week 8 post-intervention2
Change in objective motivation assessed by Effort-Expenditure for Rewards Task (EEfRT)
The EEfRT is a widely used, multi-trial task in which participants are given an opportunity on each trial to choose between two different task difficulty levels in order to obtain monetary rewards. EEfRT will be used as an objective measure of motivation, and will be administered following MRI scans during the study. The EEfRT is reported as the percent of high effort trials selected. A higher percentage reflects higher motivation for effort expenditure.
Time frame
Baseline, week 4 post-intervention, week 8 post-intervention3
Change in Inventory of Depressive Symptomatology- Self-Report (IDS-SR)
Anhedonia will be assessed from a subscale of the IDS-SR. Scores on this 3-question scale range from 0-9 with higher scores reflecting greater anhedonia.
Time frame
Baseline, weeks 1-4 post-intervention, weeks 5-8 post-intervention4
Change in Snaith-Hamilton Pleasure Scale-Clinician (SHAPS-C)
The SHAPS-C is a clinician administered tool to assess symptoms of anhedonia. The SHAPS-C uses14 questions each rated on a Likert scale of 1-4, with higher scores reflecting greater pathology.
Time frame
Baseline, weeks 1-4 post-intervention, weeks 5-8 post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov