Young Pregnant Women More Likely To Be Depressed Than Their Mothers

MedicalResearch.com Interview with:

Rebecca Pearson, PhD Lecturer in Psychiatric Epidemiology Centre for Academic Mental Health School of Social & Community Medicine University of Bristol

Dr. Pearson

Rebecca Pearson, PhD
Lecturer in Psychiatric Epidemiology
Centre for Academic Mental Health
School of Social & Community Medicine
University of Bristol

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

Response: We know depression and anxiety are common in young women and during pregnancy when there are also implications for the developing child.

It is therefore important to investigate whether symptoms are rising given the pressures of modern life.

We found that compared to their mothers generation in the 1990s young pregnancy women today are more likely to be depressed. This was driven largely by symptoms of anxiety and feeling overwhelmed rather than feeling down.  Continue reading

Reduced Heart Rate Variability May Be Biomarker of Depression Risk

MedicalResearch.com Interview with:

Viola Vaccarino, MD, PhD Department of Epidemiology and Division of Cardiology Professor, Department of Medicine Emory University School of Medicine Atlanta, Georgia

Dr. Vaccarino

Viola Vaccarino, MD, PhD
Department of Epidemiology and Division of Cardiology
Professor, Department of Medicine
Emory University School of Medicine
Atlanta, Georgia 

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

Response: Previous studies have shown that people with depression tend to have lower heart rate variability (HRV), an index of autonomic nervous system dysregulation derived by monitoring the electrocardiogram over time, usually for 24 hours. Other literature, however, has pointed out that autonomic dysregulation (as indexed by reduced HRV) may also cause depression. Thus, the direction of the association between reduced HRV and depression still remains unclear. In addition, these two characteristics could share common pathophysiology, making shared familial background and genetic factors potential determinants of this association.
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Thyroid Inflammation Linked to Depression and Anxiety

MedicalResearch.com Interview with:
Thyroid gland Wikipedia imageTeja Grömer PD Dr. med. Habil

Facharzt für Psychiatrie und Psychotherapie
Lehrbefugter der Universität Erlangen-Nürnberg im Fach Psychiatrie
Bamberg 

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

1) I had seen hundreds of clinical cases with combined depression and anxiety and noted end of 2015 that most (far more than 50%) from the subjective clinical impression were associated with autoimmune thyroiditis (AIT)

2) Autoimmune thyroiditis on the mental side leads to specific symptoms, exhaustion, tachycardia, restlessness.

3) I thus decided to do a systematic review and meta-analysis.  Continue reading

Resistance Exercise Training May Alleviate Some Depressive Symptoms

MedicalResearch.com Interview with:
“gym” by FooJFoo is licensed under CC BY-NC-ND 3.0Mr. Brett R. Gordon, M.Sc.

Postgraduate researcher
Physical Education and Sport Sciences Department
University of Limerick, Ireland. 

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

Response: Depression is prevalent, burdensome, and often comorbid mood disorder that is associated with other poor health outcomes. Exercise training interventions have demonstrated comparable efficacy for depressive symptoms to frontline treatments, such as antidepressant medications and behavioral therapies.

However, the evidence to date has primarily focused on findings from studies of aerobic exercise training like jogging, running, and cycling. Our work is the first quantitative summary of the effects of resistance exercise training (RET), or weight lifting and strength training, on depressive symptoms, and the influence of variables like participant characteristics, features of the RET, and the methods that were used in studies on the antidepressant effects of RET.

The main finding was that resistance exercise training significantly reduced depressive symptoms among adults regardless of their health status, the total prescribed volume of RET (e.g., how much the participants were supposed to exercise), or whether or not strength was significantly improved by the RET intervention.  Continue reading

Over 2.5 Million US Kids Diagnosed With Anxiety and Depression

MedicalResearch.com Interview with:
Rebecca H. Bitsko, PhD

National Center on Birth Defects and Developmental Disabilities
Centers for Disease Control and Prevention 

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

Response: CDC’s National Center on Birth Defects and Developmental Disabilities(https://www.cdc.gov/ncbddd/index.html) (NCBDDD) is committed to helping children who have mental, emotional, and behavioral disorders. Anxiety and depression are both internalizing mental disorders that often start during childhood, and that frequently occur together.

In this study, we show that more than 1 in 20, or 2.6 million, US children aged 6-17 had a current diagnosis of anxiety or depression, by parent report, in 2011-12. We also found an increase of diagnosed anxiety in these children from 1 in 28 in 2007 to 1 in 24 in 2011-12.

Further, in 2011-12, approximately 1 in 5 children with current anxiety or depression did not receive mental health treatment in the past year.

Children with current anxiety or depression were more likely than those without to have:

  • Another mental, behavioral, or developmental disorder such as ADHD, learning disability, or speech or language problems
  • School problems
  • Parents who report high levels of stress and frustration with parenting
  • Unmet medical and mental health service needs

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Some Depression and Overactive Bladder Drugs Linked to Dementia

Medicalresearch.com Interview with:

Professor Phyo Kyaw Myint Chair in Old Age Medicine University of Aberdeen

Prof. Myint

Professor Phyo Kyaw Myint
Chair in Old Age Medicine
University of Aberdeen

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

Response: We have previously studied the potential harmful effects of a group of medications called anticholinergics. They can have side effects on central as well peripheral systems. The link between use of these drugs and dementia is less well understood due to limitations of previous studies.

We used large GP practices data from the UK with long term follow up and examined this association using robust statistical methods.

Medicalresearch.com: What are the main findings?

Response: Key findings are:

  • Drugs with anticholinergic properties which are used to treat depression, urological conditions (e.g. for overactive bladder) and Parkinsonism are linked to development of dementia.
  • Drugs with similar properties which are used to treat gut disorders and heart conditions are not found to be linked to dementia
  • Drugs with low level of anticholinergic effect are not linked to dementia

Medicalresearch.com: What should readers take away from your report?

Response: Clinicians should use the drugs with high level of anticholinergic burden cautiously. Also attempts should be made whenever appropriate to reduce or replace with similar drugs but without such properties.

Medicalresearch.com: What recommendations do you have for future research as a result of this study?

Response: We need to ensure confounding effects are minimised by conducting carefully designed prospective studies. Further clinical trial evidence of benefit of deprescribing of these medications (when possible) in at risk populations is also urgently warranted.

Medicalresearch.com: Is there anything else you would like to add? Any disclosures?

Response: In the absence of trial evidence, this study provides best available evidence using robust statistical methods in the largest study of its kind and will help clinicians in making treatment choices for the benefit of the patients.

Citation:

Anticholinergic drugs and risk of dementia: case-control study

BMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k1315 (Published 25 April 2018)Cite this as: BMJ 2018;361:k1315

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

 

 

 

Prenatal SSRI Exposure Linked to Altered Infant Brain Development

MedicalResearch.com Interview with:

Claudia I. Lugo-Candelas, PhD Postdoctoral Research Fellow Columbia University Medical Center/ New York State Psychiatric Institute

Dr. Lugo-Candelas

Claudia I. Lugo-Candelas, PhD
Postdoctoral Research Fellow
Columbia University Medical Center/ New York State Psychiatric Institute

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

Response: We have seen, in the last decade, an increase in the amount of mothers being prescribed SSRIs during pregnancy. While we know that untreated prenatal maternal depression has adverse consequences for both the mother and child, it’s not really clear what, if any, are the consequences of prenatal SSRI exposure on infant’s brain development. There have been some studies finding increased depression and anxiety in children prenatally exposed to SSRIs, but not all studies find these associations.

We thus looked at 2-4 week old infants’ brains, using neuroimaging.  We found increased gray matter volume within the amygdala and insula, and increased white matter connectivity between these two structures in infants prenatally exposed to SSRIs. Of note, the statistical significance and the size of the effects we detected are quite large, even greater than the brain changes that we usually observe in our studies of children and adults with psychiatric disorders. Further, because these structures are involved in emotion processing, and alterations in volume and connectivity are sometimes seen in clinical populations, or in people at risk for anxiety, it important to learn more about what these volume and connectivity differences could mean for these infants.

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Phase 3 Trial of Cariprazine (Vraylar) Shows Promise in Bipolar Depression

MedicalResearch.com Interview with:

Dr. C. David Nicholson, PhD Chief R&D Officer  Allergan

Dr. C. David Nicholson

Dr. C. David Nicholson, PhD
Chief R&D Officer
Allergan

MedicalResearch.com: What is the background for this data milestone? 

Response: Bipolar I depression refers to the depressive episodes of bipolar I disorder, the overarching brain and behavioral disorder. People with bipolar I disorder can have manic and depressive episodes, as well as mixed episodes that feature both manic and depressive symptoms at the same time. Bipolar I depression typically lasts at least two weeks, and can be difficult to differentiate from major depression during diagnosis.

Once diagnosed, treating bipolar depression can be difficult given the few therapies available to manage these symptoms of bipolar I disorder. Additionally, patients with bipolar disorder may experience shifts from depression to mania or mania to depression as well as mixed states. More treatment options are needed so that physicians can find a therapy that will treat bipolar depression effectively, while also addressing the myriad of other symptoms that patients can experience.

Cariprazine is already approved for the treatment of mania and mixed episodes. With this new data, we have the potential to also treat bipolar depression, effectively addressing the full spectrum of symptoms associated with bipolar I disorder with just one medication.

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Acne Sufferers At Increased Risk of Depression

MedicalResearch.com Interview with:
“Young man with acne” by Sergey Sudeykin (Russian, Smolensk 1882–1946 Nyack) via The Metropolitan Museum of Art is licensed under CC0 1.0Isabelle Vallerand, Ph.D.
Epidemiologist, MD Student
Dept. of Community Health Sciences
Cumming School of Medicine
University of Calgary

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

Response: Over the past few years, there have been numerous reports that an acne drug called isotretinoin (Accutane) has been linked to psychiatric disorders. We recently published a systematic review on this topic and did not find an increased risk of psychiatric disorders among people treated with isotretinoin, so we wondered if acne itself may be contributing to mental illness. While it is well known that acne can have negative effects on mood, we wanted to assess if there was an increased risk of true clinical depression using medical records data.

Therefore, we conducted the current study and found that acne increased the risk of developing clinical depression by 63% in the first year following an acne diagnosis and that this risk remained elevated for 5 years after the initial acne diagnosis.

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Transcranial Stimulation Has Potential as Add-On Therapy For Bipolar Depression

MedicalResearch.com Interview with:

Yokoi and Sumiyoshi. 2015 tDCS administration at National Center of Neurology and Psychiatry Hospital. A subject (front) sits on a sofa relaxed, and a researcher (behind) controls the tDCS device (a). In this picture, anodal (b) and cathodal (c) electrodes with 35-cm2 size are put on F3 and right supraorbital region, respectively. We use a head strap (d) for convenience and reproducibility, and also use a rubber band (e) for reducing resistance

tDCS administration at National Center of Neurology and Psychiatry Hospital. A subject (front) sits on a sofa relaxed, and a researcher (behind) controls the tDCS device (a). In this picture, anodal (b) and cathodal (c) electrodes with 35-cm2 size are put on F3 and right supraorbital region, respectively. We use a head strap (d) for convenience and reproducibility, and also use a rubber band (e) for reducing resistance
Wikipedia file

Andre Russowsky Brunoni, MD, PhD
Coordinator, Service of Interdisciplinary Neuromodulation, Laboratory of Neurosciences  Department and Institute of Psychiatry
Coordinator, Interdisciplinary Center for Applied Neuromodulation, University Hospital
University of São Paulo
São Paulo, Brasil 

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

Response: In this study, our aim was to evaluate the safety and efficacy of transcranial direct current stimulation (tDCS) as an add-on treatment for patients with bipolar depression. There are a only few treatment alternatives for bipolar depression, which often have important side effects. Thus, we wanted to evaluate the efficacy of this non-pharmacological treatment.

We found that active vs. sham tDCS effected greater response and remission for patients with bipolar depression. The frequency of adverse effects was similar, including treatment-emergent affective switches. However, higher rates of skin redness were observed in the active group.

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Common Antidepressant Sertraline Does Not Improve Depression in Chronic Kidney Disease Patients

MedicalResearch.com Interview with:

Dr. Susan Hedayati MD University of Texas Southwestern Dallas, Texas

Dr. Hedayati

Dr. Susan Hedayati MD
Yin Quan-Yuen Distinguished Professorship in Nephrology
University of Texas Southwestern
Dallas, Texas

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

Response: We previously showed that Major Depression is associated with a significantly higher risk of death, dialysis initiation, and hospitalization among patients with Chronic Kidney Disease (CKD). Now we show that a common antidepressant medication, a selective serotonin reuptake inhibitors (SSRI), sertraline, does not improve depression in this patient population, a chronically ill group that is not only at significantly increased risk for developing depression but also its serious complications.

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Migraines More Frequent With Increased Anxiety and Depression

MedicalResearch.com Interview with:

“Headache.” by Avenue G is licensed under CC BY 2.0

“Headache.” by Avenue G

Fu-Chi Yang, M.D., Ph.D.Assistant Professor
Department of Neurology,
Tri-Service General Hospital
National Defense Medical Center
Taipei, Taiwan

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

Response: Migraineurs are likely to suffer from comorbid depression and anxiety. Furthermore, increased migraine frequency is associated with an increased risk of mood/anxiety disorders. It is not distinguished by grouping frequency of migraine attacks, whether it is associated with severity scores of depression and anxiety. Thus, we evaluated the relationship between severity of depression/anxiety and migraine frequency

We mainly found that the severity of depression (BDI and HADS-depression scores) and anxiety (HADS anxiety score) were related to migraine frequency, after adjusting confounding factors.

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Alzheimer’s: Antidepressants Increase Risk of Head and Traumatic Brain Injuries

MedicalResearch.com Interview with:

Heidi Taipale, PhD Pharm Senior Researcher School of Pharmacy, University of Eastern Finland; and Department of Clinical Neuroscience Karolinska Institutet 

Dr. Taipale

Heidi Taipale, PhD Pharm
Senior Researcher
School of Pharmacy, University of Eastern Finland; and
Department of Clinical Neuroscience
Karolinska Institutet 

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

Response: Antidepressant use among older persons has been associated with an increased risk of falling and fall-related events, such as hip fractures, in previous studies. Our previous study identified risk of hip fractures in antidepressant among persons with Alzheimer’s disease. As falling is the main causal factor for head traumas and traumatic brain injuries among older persons, we hypothesized that antidepressant use could also be associated with these injuries.

We utilized a nationwide cohort of 70,718 persons newly diagnosed with Alzheimer’s disease, identified from the Finnish registers. The risk of head injuries and traumatic brain injuries was compared between persons initiating antidepressant use and comparison persons of the same age, gender and time since they received diagnoses of Alzheimer’s disease but not using antidepressants. We found a 40-percent increased risk of head injuries and 30-percent increased risk of traumatic brain injuries associated with antidepressant use. Antidepressant use was associated with a higher risk of head injuries especially at the beginning of use – during the first 30 days – but the risk persisted even longer, up to two years. The association was also confirmed in a study design comparing time periods within the same person, thus eliminating selective factors. Continue reading

Brain Imaging Confirms Boys and Girls Experience Depression Differently

MedicalResearch.com Interview with:

Jie-Yu Chuang PhD Department of Psychiatry University of Cambridge Cambridge, United Kingdom

Dr. Jie-Yu Chuang

Jie-Yu Chuang PhD
Department of Psychiatry
University of Cambridge
Cambridge, United Kingdom 

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

Response: Men and women appear to suffer from depression differently, and this is particularly striking in adolescents. By 15 years of age, girls are twice as likely to suffer from depression as boys. There are various possible reasons for this, including body image issues, hormonal fluctuations and genetic factors, where girls are more at risk of inheriting depression. However, differences between the sexes don’t just involve the risk of experiencing depression. Men are more liable to suffer from persistent depression, whereas in women depression tends to be more episodic. Compared with women, depressed men are also more likely to suffer serious consequences from their depression, such as substance abuse and suicide. Despite this, so far, most researchers have focused on depression in women, likely because it is more common. As a result, we’d like to make people more aware of the sex difference issue in depression.

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Study Helps Explains Why Dopamine Drugs Not Effective For Depression

MedicalResearch.com Interview with:

Robb B. Rutledge, PhD Max Planck University College London Centre for Computational Psychiatry  and Ageing Research University College London London, England

Dr. Rutledge

Robb B. Rutledge, PhD
Max Planck University College London Centre for Computational Psychiatry
and Ageing Research
University College London
London, England

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

Response: Depression is associated with deficits in how the brain responds to rewards, something the neurotransmitter dopamine is strongly implicated in.

Dopamine represents what is called a reward prediction error, the difference between experienced and predicted reward. This error signal is used for learning. For example, if the outcome of a decision is better than expected, you can update your expectations using this error signal and you should expect more next time. Previous research has shown that depression reduces these signals in the brain when people are learning about the world around them. We designed a task where participants did not have to learn anything during the experiment and we found that in this situation reward prediction error signals were not affected by depression. The signals we measured in the ventral striatum, a brain area with a lot of input from the dopamine neurons, looked the same in depressed and non-depressed individuals. We also found that the emotional impacts of reward prediction errors were similar in depressed and non-depressed individuals when we eliminated the need for learning during the task in both the lab and using a smartphone experiment with 1833 participants.

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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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