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Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression (PRECISE-D)

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ClinicalTrials.gov Identifier: NCT03993457
Recruitment Status : Recruiting
First Posted : June 20, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Depression Drug: Escitalopram Drug: Bupropion Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will be assigned to one of two groups based on their CRP levels:

  • CRP less than 1
  • CRP greater than or equal to 1

Participants within both groups will then be randomized to one of 2 groups, which is stratified by a CRP group:

  • CRP consistent antidepressant selection (medication will be prescribed based on CRP level)
  • CRP inconsistent antidepressant selection (medication will be prescribed in contradiction to CRP level)
Masking: None (Open Label)
Masking Description: Participant, care provider, investigator, and outcomes assessor will only be blinded to the participant's CRP levels and group assignment. However, the study is open label, meaning the participant, care provider, investigator, and outcomes assessor will know what medication the participant is taking.
Primary Purpose: Treatment
Official Title: Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021


Arm Intervention/treatment
CRP<1, CRP consistent antidepressant selection
Participants with CRP<1 will be prescribed escitalopram
Drug: Escitalopram
Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
Other Name: Lexapro

CRP> or equal to 1, CRP consistent antidepressant selection
Participants with CRP> or equal to 1 will be prescribed bupropion XL
Drug: Bupropion
Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
Other Name: Wellbutrin XL

CRP<1, CRP inconsistent antidepressant selection
Participants with CRP< 1 will be prescribed bupropion XL
Drug: Bupropion
Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
Other Name: Wellbutrin XL

CRP> or equal to 1, CRP inconsistent antidepressant selection
Participants with CRP> or equal to 1 will be prescribed escitalopram
Drug: Escitalopram
Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
Other Name: Lexapro




Primary Outcome Measures :
  1. Efficacy of CRP-consistent antidepressant selection versus CRP-inconsistent antidepressant selection on remission rates in patients with MDD. [ Time Frame: 1 year ]
    The primary study endpoint will be remission rates based on the 16-items Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR), which will be extracted from the 30-item Inventory of Depressive Symptomatology (IDS-SR). The QIDS-SR score ranges from 0-27. A score of 5 or less represents remission.

  2. Efficacy of CRP-consistent antidepressant selection versus CRP-inconsistent antidepressant selection on improving social and occupational functioning. [ Time Frame: 1 year ]
    Improvement in social and occupational functioning will be measured with the 5-item self-administered Work and Social Adjustment Scale (WSAS). The WSAS total score ranges from 0-40. Lower scores are better.

  3. Adverse antidepressant treatment effects on CRP-consistent antidepressant selection versus CRP-inconsistent antidepressant selection [ Time Frame: 1 year ]
    Side effects will be assessed using the 3-item self-administered Frequency, Intensity, and Burden of Side Effects (FIBSER). Each item is scored on a scale from 0-6. Items 1 and 2 (Frequency & Intensity respectively) are to provide information to the clinician, but they are not used in the scoring.The score that is used comes only from Item 3 - Burden. Lower scores represents lower burden.


Secondary Outcome Measures :
  1. Optional Sub-study. Validity and reliability of capillary blood CRP measurement [ Time Frame: 1 year ]
    Capillary blood CRP levels will be compared with those obtained using venous blood obtained via venipuncture.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03993457


Contacts
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Contact: Maria Monastirsky 214 648 4357 cdrc@utsouthwestern.edu
Contact: Catherine Huff 214 648 4357 cdrc@utsouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Maria Monastirsky    214-648-4357    cdrc@utsouthwestern.edu   
Sub-Investigator: Gustavo Costa Madeiros, MD         
Sub-Investigator: Tracy Greer, PhD         
Sub-Investigator: Nancy de la Garza, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Madhukar H Trivedi, MD UTSW

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Responsible Party: Madhukar H. Trivedi, MD, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03993457     History of Changes
Other Study ID Numbers: STU-2019-0623
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center:
depression
mental health
mood disorders
major depressive episode
major depressive disorder
antidepressants
escitalopram
bupropion
depression treatment
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Antidepressive Agents
Citalopram
Bupropion
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors