Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression

• Status: Active, not recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

PRECISE-D is a single site, randomized, open label 8-week clinical trial that will enroll 70 participants to evaluate if the level of inflammation in our body can predict how we will respond to antidepressants. C-reactive protein (CRP) is a substance in the body that is associated with inflammation. Previous research has suggested that people with high CRP (i.e., high inflammation levels) tend to have greater improvement of depressive symptoms with an antidepressant called bupropion, while individuals with low CRP (i.e., low inflammation levels) appear to have more benefit from selective serotonin reuptake inhibitors antidepressants (SSRI), such as escitalopram. However, it is not completely clear if CRP can predict your response to these two antidepressants.

Participants will undergo a screening visit that includes a physical exam, overall health evaluation, assessment of mental health history, and a toxicology and pregnancy test. Once screening is complete, participants will be randomized to one of two groups that will determine whether their CRP levels will be used to select which antidepressant they will receive. Participants will then complete 4 follow up visits at weeks 2, 4, 6, and 8. A follow-up phone call from the study team will occur at week 12.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Antidepressive Agents; Bupropion; Citalopram; Dexetimide

Criteria

Inclusion Criteria:

• Women and men ages 18-65

• Current diagnosis of Major Depressive Disorder

• Able to read, speak, and understand English

Exclusion Criteria:

• Antidepressant use within the last 8 weeks

• Active infection or uncontrolled autoimmune disease

• Currently on oral corticosteroids or active immune suppressive therapy (methotrexate, cyclosporine, anti-cytokines medications, etc).

• Current diagnosis of uncontrolled HIV, hepatitis C or significant immunodeficiency

• Alcohol or substance use disorder

• Positive urine drug test for illicit substances or substances used out of the context of prescription

• Cognitively unable to give informed consent

• Pregnant or breastfeeding women, women of childbearing potential who are not using an accepted means of birth control, or women with a positive urine pregnancy test

• History of seizure disorder

• Previous significant adverse reaction to escitalopram or bupropion

• History of non-response to adequate doses of escitalopram or bupropion XL

• Current use of concomitant psychotropic agents (anticonvulsants, benzodiazepines, hypnotics, opiates, triiodothyronine (T3), modafinil, psychostimulants, buspirone, melatonin, folate, l-methylfolate, s-adenosyl methionine, lithium) not on the same dose for at least four weeks prior to study entry or who do not agree to continue at the same dose during the acute phase of the study.

• Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder or other psychotic disorder

• Current anorexia nervosa or bulimia nervosa

• Suicidal ideation of the degree that, in the opinion of the evaluating clinician, participation in the study would place them at significantly increased risk of suicide

• Unstable medical issues of such degree that, in the opinion of the evaluating clinician, participation in the study would place them at significant risk of a serious adverse event