The Efficacy of Buprenorphine in Major Depression, Treatment-Resistant Depression and Suicidal Behavior: A Systematic Review

Serafini, Gianluca; Adavastro, Giulia; Canepa, Giovanna; Berardis, Domenico De; Valchera, Alessandro; Pompili, Maurizio; Nasrallah, Henry A.; Amore, Mario

doi:10.3390/ijms19082410

Cited by 111 publications

(63 citation statements)

References 58 publications

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“…Historically, prior to the advent of monoaminergic antidepressants, opioids were used to treat MDD, a practice sometimes referred to as the “opium cure”. 20 More recently, buprenorphine (BUP) has been shown in clinical trials to possess antidepressant activity, particularly in treatment-refractory patients 20–24. However, the clinical utility of opioids has been limited by the risk of abuse and dependence 22…”

Section: Introductionmentioning

confidence: 99%

<p>Buprenorphine/samidorphan combination for the adjunctive treatment of major depressive disorder: results of a phase III clinical trial (FORWARD-3)</p>

Zajecka¹,

Stanford²,

Memişoğlu³

et al. 2019

NDT

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Background The endogenous opioid system is a fundamental regulator of mood in humans. Previously reported clinical trials have demonstrated the efficacy of the investigational agent buprenorphine/samidorphan (BUP/SAM) combination, an opioid-system modulator, for the adjunctive treatment of major depressive disorder. We present here a third phase III study of different design. Methods Adult patients with major depressive disorder and inadequate response to antidepressant therapy were enrolled in this double-blind, placebo-controlled, placebo run-in study to evaluate the efficacy, safety, and tolerability of adjunctive BUP/SAM 2 mg/2 mg. Patients with baseline Hamilton Depression Rating Scale score $20 received double-blind placebo in addition to background antidepressant therapy for 4 weeks. Nonresponders were randomized to receive adjunctive BUP/SAM 2 mg/2 mg or placebo for 6 weeks. The primary end point was change in Montgomery–Åsberg Depression Rating Scale (MADRS)-10 total score from randomization at baseline to the end of the 6-week treatment period. Results Least-squares mean change in MADRS-10 score at end of treatment was -4.8 (SE 0.67) in the BUP/SAM 2 mg/2 mg group and -4.6 (SE 0.66) in the placebo group (mean difference -0.3 [SE 0.95], P =0.782). There were no differences in MADRS-based response or remission rates. Overall, 42.9% of the BUP/SAM 2 mg/2 mg group and 34.5% of the placebo group experienced at least one treatment-emergent adverse event during the 6-week treatment period, most of which were mild or moderate in severity. There were no clinically important changes in laboratory parameters, weight, or vital signs and no evidence of abuse potential during treatment or opiate-withdrawal symptoms post treatment. Conclusion Efficacy results in FORWARD-3 measured by change in MADRS-10 score did not meet the primary end point, but postbaseline improvement in MADRS-10 in the BUP/SAM 2 mg/2 mg group was consistent with that seen in previously reported trials. BUP/SAM 2 mg/2 mg was well tolerated.

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Section: Introductionmentioning

confidence: 99%

<p>Buprenorphine/samidorphan combination for the adjunctive treatment of major depressive disorder: results of a phase III clinical trial (FORWARD-3)</p>

Zajecka¹,

Stanford²,

Memişoğlu³

et al. 2019

NDT

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“…κ-Opioid receptors may play an important role in buprenorphine therapeutics, especially for patients with comorbid depression. The antidepressant effects displayed by buprenorphine are related to its antagonistic activity at these receptors [ 39 , 40 ] . Uncontrolled psychiatric illnesses can negatively impact OUD treatment outcomes, and thus, a medication that could potentially provide benefits for both disorders would be clinically advantageous [ 53 , 54 ] .…”

Section: Pharmacogenes: Opioid Receptorsmentioning

confidence: 99%

“…Partial agonism leads to effective analgesic effects and abatement of withdrawal symptoms while reducing the risk of respiratory depression observed with methadone and other opioids [ 20 ] . Additionally, due to its effects on κ-receptors, clinical data have suggested that buprenorphine may possess antidepressant benefits, potentially representing a better option for patients with comorbid depression [ 39 , 40 ] . Buprenorphine has also been co-formulated with naloxone as a sublingual film or tablet to discourage intravenous administration, which results in the immediate onset of euphoric effects [ 20 ] .…”

Section: Introductionmentioning

confidence: 99%

A review of the pharmacogenomics of buprenorphine for the treatment of opioid use disorder

Seguí¹,

Melin²,

Santiago³

et al. 2020

jtgg

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As the opioid epidemic continues to grow across the United States, the number of patients requiring treatment for opioid use disorder continues to climb. Although medication-assisted treatment presents a highly effective tool that can help address this epidemic, its use has been limited. Nonetheless, with easier dosing protocols (compared to the more complex dosing required of methadone due to its long and variable half-life) and fewer prescribing limitations (may be prescribed outside the setting of federally approved clinics), the increase in buprenorphine use in the United States has been dramatic in recent years. Despite buprenorphine’s demonstrated efficacy, patient-specific factors can alter the response to the medications, which may lead to treatment failure in some patients. Clinical characteristics (sex, concurrent medications, and mental health comorbidities) as well as social determinants of health (housing status, involvement with the criminal justice system, and socioeconomic status) may impact treatment outcomes. Furthermore, a growing body of data suggests that genetic variations can alter pharmacological effects and influence therapeutic response. This review will cover the available pharmacogenomic data for the use of buprenorphine in the management of opioid use disorders. Pharmacogenomic determinants that affect opioid receptors, the dopaminergic system, metabolism of buprenorphine, and adverse events are discussed. Although much of the existing data comes from observational studies, clinical research is ongoing. Nevertheless, the development of pharmacogenomic-guided strategies has the potential to reduce opioid misuse, improve clinical outcomes, and save healthcare resources.

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“…The augmentation approach may include antipsychotics, mood stabilizers, anxiolytics, lithium, thyroid hormone, or other drugs. Currently, many new treatment solutions for depressive patients are developed and studied, such as repetitive transcranial magnetic stimulation (rTMS) (8), intravenous/intranasal ketamine (9), inhaled nitrous oxide (10), valgus nerve stimulation (11), deep brain stimulation (12), buprenorphine (13), etc.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of the Whole-Body Cryotherapy as Add-on Therapy to Pharmacological Treatment of Depression—A Randomized Controlled Trial

et al. 2020

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Introduction: Accumulating evidence indicates the effectiveness of cryogenic temperature interventions in rheumatoid arthritis, ankylosing spondylitis, fibromyalgia, multiple sclerosis, and chronic low back pain. The application of whole-body cryotherapy (WBC) in psychiatric aspects of medicine was also noted. Nevertheless, the exact mechanisms explaining the beneficial effect of WBC on mood disorders remain unclear. The study aimed to assess the efficacy of repetitive short exposure to extremely low temperatures (WBC) on mood, quality of life as well as on biochemical measures among people diagnosed with depressive episode undergoing pharmacological treatment. Materials and Methods: Prospective randomized, double-blind sham-controlled protocol was used. The study enrolled 92 medically stable adults (aged 20-73 years) with a diagnosis of a depressive episode. The participants were randomly allocated and exposed to 10 whole-body cryotherapy (WBC) sessions (−110°C till −160°C [the experimental group (EG)] or to low, but not cryogenic temperatures −50°C [the control group (CG)]. Thirty participants in the EG and 26 in CG completed the whole study. The primary outcome measures were depressive symptoms evaluated with the Beck Depression Inventory-II (BDI-II) as well as the Hamilton Depression Rating Scale (HAM-D 17). The quality of life, quality of sexual life, acceptance of the disease and self-reported mood, vitality, and sleep quality were assessed as secondary outcome measures. The study was registered at Australian New Zealand Clinical Trials Registry (ACTRN12619001600134). Results: The results show evidence for a statistically significant difference in the clinical assessment of depressive symptoms according to HAM-D 17 scale (T4 by group interaction p=0.02), BDI-II (T2 time by group interaction p=0.01), cognitive-affective BDI dimension (T4 by group interaction p=0.00), and somatic BDI dimension (T4 by group

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The Efficacy of Buprenorphine in Major Depression, Treatment-Resistant Depression and Suicidal Behavior: A Systematic Review

Cited by 111 publications

References 58 publications

<p>Buprenorphine/samidorphan combination for the adjunctive treatment of major depressive disorder: results of a phase III clinical trial (FORWARD-3)</p>

<p>Buprenorphine/samidorphan combination for the adjunctive treatment of major depressive disorder: results of a phase III clinical trial (FORWARD-3)</p>

A review of the pharmacogenomics of buprenorphine for the treatment of opioid use disorder

Efficacy of the Whole-Body Cryotherapy as Add-on Therapy to Pharmacological Treatment of Depression—A Randomized Controlled Trial

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