Brexanolone Shows Promise in PostPartum Depression

MedicalResearch.com Interview with:

Samantha Meltzer-Brody, MD, MPH Associate Professor and Associate Chair for Faculty Development Director, Perinatal Psychiatry Program Director, Taking Care of Our Own Program Department of Psychiatry Chapel Hill, NC 2759

Dr. Meltzer-Brody

Samantha Meltzer-Brody, MD, MPH
Associate Professor and Associate Chair for Faculty Development
Director, Perinatal Psychiatry Program
Director, Taking Care of Our Own Program
Department of Psychiatry
Chapel Hill, NC 2759 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The Lancet published results from a randomized, placebo-controlled, phase 2 clinical trial with the investigational medication, brexanolone, for women with severe postpartum depression (PPD). During the study, which was conducted at multiple sites across the country, physician researchers administered brexanolone in 21 women, 10 of whom were administered a 60-hour infusion of brexanolone. The other 11 women were given a placebo. Results from the trial showed that 70 percent of participants who received the drug saw remission of their PPD symptoms within 60 hours of treatment, an effect that was maintained until the 30-day follow up.

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New Simultaneous Antidepressant and Benzodiazepine Use Relatively Common

MedicalResearch.com Interview with:

Greta A Bushnell, MSPH Doctoral Candidate, Department of Epidemiology UNC, Gillings School of Global Public Health

Greta Bushnell

Greta A Bushnell, MSPH
Doctoral Candidate, Department of Epidemiology
UNC, Gillings School of Global Public Health

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Patients with depression may be co-prescribed a benzodiazepine at antidepressant initiation for a short period for a variety of reasons. Reasons include reducing concurrent anxiety and insomnia, reducing depression severity more quickly, and improved antidepressant continuation. However, there are concerns with benzodiazepines including dependency. As such, benzodiazepines are usually recommended for only short-term treatment.

Prior to our study, little was known about a) how often new simultaneous antidepressant and benzodiazepine prescribing occurred among patients initiating antidepressant treatment for depression or b) whether new simultaneous users became long-term benzodiazepine users.

In a large commercial insurance database, we identified adults aged 18-64 years with depression who initiated an antidepressant from 2001 to 2014. We found that 11% of adults simultaneously initiated benzodiazepine treatment, which increased from 6% in 2001 to a peak at 12% in 2012. We observed similar antidepressant treatment length at six months in simultaneous new users and among patients initiating antidepressants only. The majority of simultaneous new users had only one benzodiazepine prescription fill before benzodiazepine discontinuation; however, 12% were identified as long-term benzodiazepine users.

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Pain and Depression in ESRD- End Stage Renal Disease

MedicalResearch.com Interview with:
Kathy Aebel-Groesch, MSW,LCSW
Manager, Social Work Services
DaVita Inc.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Chronic pain and depression can impact quality of life and adherence to treatment regimen among patients with end-stage renal disease (ESRD). Previous research has demonstrated that patients with ESRD experience pain and depression more frequently than the general population. From 2016, CMS has required that all eligible ESRD patients are evaluated regularly for pain and depressive symptoms.

We assessed pain and depression symptom scores among patients of a large dialysis organization (LDO) over the period Mar-Oct 2016. Pain was assessed monthly by LDO nurses using the Wong-Baker pain scale (0-10). Depression screenings were conducted biannually by LDO social workers using the PHQ-2 (scale 0-6) and excluded patients with existing diagnosis of depression or bipolar disorder, cognitive impairment or language barrier, and those who were hospitalized or refused screening.

A total of 688,346 pain responses from 160,626 individual patients and 223,421 depression screening responses from 158,172 patients were considered. A score of 0 (no pain) was reported for 83.5% of pain responses and 65.7% of patients had a 0 score in all pain assessments. A score of 10 (most severe pain) was reported at least once during the study period by 3.0% of patients. Patients with a pain score of 10 were more frequently female (55%) and patients on peritoneal dialysis were less likely to have a pain score of 10 than those on other modalities. A depression score of 0 (patient answered “Not at all” to both “Little interest or pleasure in doing things” and “Feeling down, depressed, or hopeless”) was reported for 69.1% of all responses and 62.6% of patients had a 0 score in all assessments; 1.8% of patients had at least one score of 6 (patient responded “Nearly every day” to both questions) and 9.7% had at least one score of 3 or more. Patients with a score of 0 were more likely to be male vs. female, HHD vs. PD or ICHD, ≥ age 70 years.

The majority of ESRD patients did not report pain symptoms and, among those not excluded from screening due to an existing diagnosis of depression or other reason, the majority did not report symptoms of depression. However, routine assessment of pain and depression enables the timely identification of new or increased symptoms, thus allowing earlier implementation of interventions that may improve patient experience. The LDO has since revised its depression screening policy to remove diagnosis of depression from exclusion criteria and to administer the PHQ-9 to patients with a PHQ-2 score ≥ 3.

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Acupuncture Therapy and Incidence of Depression After Stroke

MedicalResearch.com Interview with:
Chung-Yen Lu, MD, PhD

Assistant Professor
Department of Sport and Health Management, Da-Yeh University, Changhua, Taiwan; Department of Chinese Medicine, Taipei Hospital, Ministry of Health and Welfare,
New Taipei, Taiwan 

MedicalResearch.com: What is the background for this study?

Response: Post-stroke depression is a common mood complication of patients with stroke and may deteriorate motor function and cognitive function. Acupuncture therapy is an alternative and supplementary medical care often used worldwide. Previous studies have reported that acupuncture therapy for post-stroke depression may involve multiple therapeuticeffects including treating neurological disorders and physical disabilities following stroke, which are predictors of post-stroke depression. However, population-based evaluations on the association between acupuncture treatment and prevention of post-stroke depression are rare.  Continue reading

Microvascular Disease Linked To Late-Life Depression

MedicalResearch.com Interview with:

Miranda T. Schram PhD Associate professor Department of Medicine Maastrich

Dr. Schram

Miranda T. Schram PhD
Associate professor
Department of Medicine
Maastrich

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Late-life depression, also called vascular depression, is highly prevalent, recurrent and difficult to treat. Anti-depressants only relieve symptoms in about 50% of the patients. So we urgently need new treatment targets for this disease.

In this study we found that microvascular dysfunction, irrespective if you measure this by biomarkers in the blood or in the brain, is associated with an increased risk for depression. Moreover, we found evidence from longitudinal studies that microvascular dysfunction, at least of the brain, may actually be a cause of depression. To investigate this, we undertook a meta-analyses of data from over 40,000 individuals of whom over 9,000 had a depression.

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LATUDA Phase 3 Study Demonstrates Improvement in Pediatric and Adolescent Bipolar Depression

MedicalResearch.com Interview with:

Antony Loebel, M.D. Executive Vice President and Chief Medical Officer Sunovion, Head of Global Clinical Development Sumitomo Dainippon Pharma Group

Dr. Loebel

Antony Loebel, M.D.
Executive Vice President and Chief Medical Officer
Sunovion, Head of Global Clinical Development
Sumitomo Dainippon Pharma Group

MedicalResearch.com: What is the background for this study? What are the main findings?

In the six-week, randomized, double-blind, placebo-controlled study, 347 children and adolescents (10 to 17 years of age) with bipolar depression received once-daily LATUDA flexibly dosed (20-80 mg/day) or placebo.The Phase 3 clinical study met its primary endpoint, showing statistically significant and clinically meaningful improvement in symptoms compared to placebo. LATUDA was generally well tolerated, with minimal effects on weight and metabolic parameters.

The primary efficacy endpoint was change from baseline to week 6 on the Children Depression Rating Scale, Revised (CDRS-R) total score. LATUDA was associated with statistically significant and clinically meaningful improvement in bipolar depression symptoms compared to placebo, based on CDRS-R total score (-21.0 vs. -15.3; effect size = 0.45; p<0.0001) and CGI-BP-S score for depression (-1.49 vs. -1.05; effect size = 0.44; p<0.001).

LATUDA also demonstrated statistically significant improvement on secondary efficacy endpoints.

The most common treatment-emergent adverse events reported for LATUDA compared to placebo were nausea (16% vs. 5.8%), somnolence (9.1% vs. 4.7%), weight gain (6.9% vs. 1.7%), vomiting (6.3% vs. 3.5%), dizziness (5.7% vs. 4.7%) and insomnia (5.1% vs. 2.3%). LATUDA was associated with no increases in fasting glucose or lipids, and minimal increase in mean weight vs. placebo (+0.74 kg vs. +0.44 kg).

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Depressive Symptoms Not Found To Increase Risk of Dementia

MedicalResearch.com Interview with:

Archana Singh-Manoux, PhD Research Professor (Directeur de Recherche) Epidemiology of ageing & age-related diseases INSERM U1018, France Honorary Professor University College London, UK

Dr. Archana Singh-Manoux

Archana Singh-Manoux, PhD
Research Professor (Directeur de Recherche)
Epidemiology of ageing & age-related diseases
INSERM  France
Honorary Professor
University College London, UK 

MedicalResearch.com: What is the background for this study?

Response: Depressive symptoms are common in dementia patients. Previous studies, based on older adults, show depressive symptoms in late life to be associated with an increased risk of dementia. These studies do not allow conclusions to be drawn on the causal nature of the association between depressive symptoms and dementia.

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Antidepressant May Enhance Drug Delivery to the Brain

MedicalResearch.com Interview with:

Ronald Cannon, Ph.D. Staff scientist at NIH’s National Institute of Environmental Health Sciences

Dr. Cannon

Ronald Cannon, Ph.D.
Staff scientist at NIH’s National Institute of Environmental Health Sciences

MedicalResearch.com: What is the background for this study?

Response: The protein pump, P-glycoprotein, is a major obstacle to the delivery of therapeutic drugs across the blood-brain barrier and into the central nervous system (CNS). During the last 10 years, our laboratory has studied the regulation of P-glycoprotein with the hope of treating CNS diseases.

MedicalResearch.com: What are the main findings?

Response: Our most recent finding shows that the antidepressant, amitriptyline, suppresses P-glycoprotein pump activity. The discovery is significant because P-glycoprotein restricts most CNS targeted drugs from entering the brain. If fully translatable to human patients, suppression of P-glycoprotein could allow higher levels of CNS therapeutic drugs to reach their intended target.

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Study Finds No Link To Autism, ADHD In Offspring From Antidepressant Use In Pregnancy

MedicalResearch.com Interview with:

Simone Vigod, MD, MSc, FRCPC Psychiatrist and Lead, Reproductive Life Stages Program Women’s Mental Health Program Women’s College Hospital Toronto, ON

Dr. Vigod

Simone Vigod, MD, MSc, FRCPC
Psychiatrist and Lead, Reproductive Life Stages Program
Women’s Mental Health Program
Women’s College Hospital
Toronto, ON

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Depression is one of the most common problems that can complicate a pregnancy. Untreated, or incompletely treated, it can be associated with significant harm to mother and child. While psychotherapies alone may be effective for women with mild (or even moderate) severity symptoms, sometimes antidepressant medication is required. In these cases, the benefits of treatment must be weighed against potential risks. Previous research suggested that there may be an increased risk for autism in children exposed to antidepressant medication during pregnancy. However, previous studies were limited in their ability to account for other potential causes of autism in their analyses. In our study, we used several different strategies to try to compare children whose pregnancy exposures were very similar, except for exposure to an antidepressant.

The main finding was that after using these strategies, there was no longer a statistically significant association between in-utero antidepressant exposure and autism.

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Review of Risk for Autism Spectrum Disorders According to Period of Prenatal Antidepressant Exposure:

MedicalResearch.com Interview with:
Florence Gressier MD PhD

Insermk Department of psychiatry
CHU de Bicêtrem Le Kremlin Bicêtre
France

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Results from recent studies have suggested an increased risk for Autism Spectrum Disorders (ASDs) in children exposed to antidepressants in utero.

We performed a systematic review of and a meta-analysis of published studies to assess the association between ASDs and fetal exposure to antidepressants during pregnancy for each trimester of pregnancy and preconception.

Our systematic review and meta-analysis suggests a significant association between increased ASD risk and maternal use of antidepressants during pregnancy; however, it appears to be more consistent during the preconception period than during each trimester. In addition, the association was weaker when controlled for past maternal mental illness. Maternal psychiatric disorders in treatment before pregnancy rather than antenatal exposure to antidepressants could have a major role in the risk for Autism Spectrum Disorders.

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