Combination Therapies for Depression with Kidney Disease
(CONCORD Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Stony Brook University
Must not be taking: Anti-arrhythmics, MAO inhibitors, Serotonergics, others
Disqualifiers: Dialysis, Hepatic dysfunction, Seizure disorder, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing two new ways to treat depression in people with chronic kidney disease. One method uses therapy sessions over the phone or internet, and the other uses a medication called bupropion. If one method doesn't work after a certain period, the other is added. The goal is to see if these treatments can improve depression and overall health in these patients. Bupropion is a second-generation antidepressant commonly used to treat depression, including in patients with chronic kidney disease.
Will I have to stop taking my current medications?
Yes, you will need to stop taking certain medications, including any ongoing antidepressant medications, serotonergic drugs, and some other specific medications listed in the exclusion criteria.
What data supports the effectiveness of the treatment Behavioral Activation Therapy for depression in patients with kidney disease?
Behavioral Activation Therapy is shown to be effective in reducing depression by encouraging enjoyable activities that boost mood, and it can be used alone or with antidepressant medication. It has been proven to improve symptoms of depression and quality of life in various settings.
12345Is bupropion generally safe for humans?
Bupropion is generally considered safe for humans, with minimal adverse events reported in clinical trials. However, seizures are a known side effect, especially in cases of overdose.
678910How is the treatment Behavioral Activation Therapy with Bupropion unique for depression in kidney disease patients?
This treatment combines Behavioral Activation Therapy, which is a simple and cost-effective approach to help people engage in activities that improve mood, with Bupropion, a medication that can boost mood and energy. This combination may offer a novel approach for treating depression in patients with kidney disease, where standard treatments might be limited.
1112131415Eligibility Criteria
Adults aged 18+ with chronic kidney disease stages 3b-5 and a confirmed diagnosis of Major Depressive Disorder. Participants must have a specific level of depressive symptoms, be able to consent, and not be on dialysis. Exclusions include significant liver issues, certain severe diseases, seizure disorders, use of conflicting medications or supplements, substance abuse needing detoxification, psychosis or bipolar disorder history.Inclusion Criteria
Able to understand and sign informed consent after the nature of the study has been fully explained
I am an adult with chronic kidney disease in stages 3b, 4, or 5 and my kidney function is below normal.
I am 18 years old or older.
+5 more
Exclusion Criteria
I am taking medication that can affect my heart's rhythm.
I am on long-term dialysis.
I am currently taking medication or supplements that affect serotonin levels.
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Phase 1
Participants receive either Behavioral Activation Teletherapy (BAT) plus placebo or bupropion plus Clinical Management for 8 weeks
8 weeks
Visits at weeks 4, 6, and 8
Treatment Phase 2
Non-remitters receive combination therapy with BAT and bupropion for an additional 8 weeks
8 weeks
Visits at weeks 8, 12, and 16
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing the effectiveness of Behavioral Activation Teletherapy (BAT) and bupropion (a non-SSRI antidepressant) against placebo in improving depression in CKD patients. It's structured so that if there's no improvement after 8 weeks for some patients, they'll receive an additional treatment. The study aims to see if these treatments can also improve medication adherence and overall quality of life.
3Treatment groups
Active Control
Placebo Group
Group I: Strategy 1Active Control2 Interventions
Strategy 1: Single-blind Behavioral Activation Therapy plus placebo for 8 weeks (Phase 1), augmented in non-remitters at 8 weeks with single-blind bupropion (Phase 2) for another 8 weeks.
Group II: Strategy 2Active Control2 Interventions
Strategy 2: Double-blind bupropion plus single-blind Clinical Management (CM) attention control for 8 weeks (Phase 1), augmented in non-remitters at 8 weeks with single-blind BAT (Phase 2) for another 8 weeks.
Group III: ControlPlacebo Group2 Interventions
Control: Clinical management attention control plus placebo for 16 weeks
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stony Brook University Medical CenterStony Brook, NY
Parkland Health and Hospital SystemDallas, TX
UT Southwestern and AffiliatesDallas, TX
University of WashingtonSeattle, WA
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Who Is Running the Clinical Trial?
Stony Brook UniversityLead Sponsor
University of Texas Southwestern Medical CenterLead Sponsor
University of WashingtonCollaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Internet-Based Behavioral Activation for Depression: Systematic Review and Meta-Analysis. [2023]Behavioral activation is an effective treatment for reducing depression. As depressive disorders affect many people worldwide, internet-based behavioral activation (iBA) could provide enhanced treatment access.
A Narrative Review of Empirical Literature of Behavioral Activation Treatment for Depression. [2022]Grounded in the profound tradition of behaviorism theory and research, behavioral activation (BA) has become a standalone psychotherapy for depression. It is simple, straightforward, and easy to comprehend, with comparable efficacy to traditional CBT, and has developed into an evidence-based guided self-help intervention. The main work in the theoretical models and treatment manuals, as well as empirical evidence of the effectiveness of BA for (comorbid) depression in primary and medical care setting are introduced. With the rise of the third wave of CBT, therapeutic components across diagnoses will be incorporated into BA (e.g., mindfulness). Extensive studies are required to examine the neurobiological reward mechanism of BA for depression, and to explore the feasibility and necessity of e-mental health BA application into the public healthcare system in China.
Explaining the Efficacy of an Internet-Based Behavioral Activation Intervention for Major Depression: A Mechanistic Study of a Randomized-Controlled Trial. [2022]Behavioral activation is an effective treatment for depression that is theorized to facilitate structured increases in enjoyable activities that increase opportunities for contact with positive reinforcement; to date, however, only few mechanistic studies focused on a standalone intervention.
Behavioral activation: a strategy to enhance treatment response. [2014]Behavioral activation is an empirically validated treatment for depression pioneered in 1973 by Ferster, based on B.F. Skinner's behavioral principles. After publication of Beck's work on cognitive therapy, the boundaries of behavioral and cognitive therapies were blurred and the two now overlap substantially. Behavioral activation is also used as a stand-alone treatment and can also be effective in conjunction with antidepressant medication. Case conceptualization in behavioral activation entails an assessment of the behaviors that the patient has stopped that produce pleasure or are of importance, as well as behaviors essential to self-care. Activity monitoring, which provides treatment targets and leads to the case conceptualization in behavioral activation, consists of using charts, forms, or other prompts to track the relationship between activities and other variables (e.g., mood, enjoyment). That technique is also used to target rumination, procrastination, and avoidance and may also be helpful for patients with psychosis.
A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol. [2020]Depression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants' feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA.
Methodologic approach to adverse events applied to bupropion clinical trials. [2013]A strategy for identifying and classifying adverse events and for assessing their relationship to therapy and frequency of occurrence is presented. Data from clinical trials of bupropion (Wellbutrin), a novel antidepressant, are presented as an example. Bupropion was studied in four double-blind, placebo-controlled trials (N = 360) at dosages of 300-750 mg/day. The incidence and frequency of adverse events associated with bupropion were minimal, and correlated well with the known pharmacologic and clinical properties of this new antidepressant.
Neuropsychiatric Safety and Efficacy of Varenicline, Bupropion, and Nicotine Patch in Smokers With Psychotic, Anxiety, and Mood Disorders in the EAGLES Trial. [2020]Neuropsychiatric safety and relative efficacy of varenicline, bupropion, and transdermal nicotine patch (NRT) in those with psychiatric disorders are of interest.
Charcoal hemoperfusion in bupropion overdose. [2016]Bupropion is a relatively new and popular medication for depression, with seizures as its major side effect. In the literature, there are insufficient data about hemodialysis following bupropion overdose. A 23-year-old female patient was brought to our emergency department with acute change in mental status and seizure after deliberate self-poisoning with approximately 25-30 tablets of bupropion hydrochloride. Her Glasgow coma scale score was 8/15. The patient underwent hemodialysis about 4 hours later. After 4 hours of extracorporeal treatment, she became conscious and was extubated. We present a case of full recovery after charcoal hemoperfusion following a bupropion overdose.
Bupropion hydrochloride. [2019]Bupropion is a trimethylated monocyclic phenylaminoketone that is an effective antidepressant in humans. It neither is sedating, anticholinergic, nor cardiotoxic. Its mechanism of action may be related to dopamine, but remains uncertain at this time. Clinical trials comparing bupropion 300-750 mg/d with placebo show it to be superior to placebo in efficacy and as well tolerated. Bupropion, in controlled clinical trials, is as effective as amitriptyline or imipramine, with fewer side effects. The only clinically significant adverse reaction to bupropion in more than 1000 patients studied has been seizure induction at a frequency comparable with that of imipramine. Bupropion appears to be safe and effective in both adult and geriatric depressed patients. Although it appears to be safer and equally efficacious when compared with currently used antidepressants, it has not been tested by routine clinical use.
Bupropion exposures: clinical manifestations and medical outcome. [2019]Bupropion is an antidepressant and smoking cessation aid. Limited toxicological information exists for intentional and unintentional bupropion-only exposures. A retrospective review of all bupropion-only exposures reported to the Toxic Exposure Surveillance System from 1998 through 1999 was conducted. Data for the three bupropion products, Wellbutrin, Wellbutrin SR, and Zyban, included demographics, reason for exposure, clinical effects, therapy, and medical outcome. A total of 7,348 bupropion-only exposures were reported: 56% female and 61% unintentional. The majority of exposures involved Wellbutrin SR; however, Wellbutrin exposures involved a higher percentage of intentional overdoses and serious clinical effects. Clinical effects related to bupropion were noted in 2,247 (31%) exposures; 8% of all children
Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? [2019]Behavioral activation (BA) is receiving renewed interest as a stand-alone or as a component of cognitive-behavior therapy (CBT) for depression. However, few studies have examined which aspects of BA are most contributory to its efficacy.
[Behavioral activation programs: A tool for treating depression efficiently]. [2018]Major depressive disorder (MDD) is a debilitating disorder, and its treatment often requires complex and costly psychological therapies. Behavioral activation (BA) is a simple, effective and affordable psychotherapy recommended in the treatment of MDD.
Innovations in Practice: A randomised controlled feasibility trial of Behavioural Activation as a treatment for young people with depression. [2021]Behavioural Activation (BA) treatment effectively reduces symptoms of depression in adults and is more cost-effective than more complex therapies. Two recent systematic reviews of BA for depression in young people highlighted the need for more studies in this area.
Feasibility study of a new behavioural activation programme for young people with depressed mood. [2022]Behavioural activation (BA) is effective in adults with depression but the evidence for young people (YP) is less clear. We therefore developed and tested a new coproduced BA programme.
Treating depressive symptoms among veterans in primary care: A multi-site RCT of brief behavioral activation. [2021]Behavioral activation is ideal for embedded behavioral health providers (BHPs) working in primary care settings treating patients reporting a range of depressive symptoms. The current study tested whether a brief version of Behavioral Activation (two 30-minute appointments, 2 boosters) designed for primary care (BA-PC) was more effective than primary care behavioral health treatment-as-usual (TAU) in reducing depressive symptoms and improving quality of life and functioning.