Diagnostic and Statistical Manual of Mental Disorders

Daré Bioscience Announces Additional Positive Data from Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women and Proposed Endpoints and Patient Population for Phase 3 Program

Retrieved on: 
Wednesday, November 1, 2023
Cream, Desire, Female, FDA, Trial of the century, SST, Food, Diagnostic and Statistical Manual of Mental Disorders, Endpoint, Diagnosis, DSM-IV codes, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pelvic floor dysfunction, Embarrassment, Guilt, Female sexual arousal disorder, Arousal, FSAD, Woman, DSM-IV, PRO, Pharmaceutical industry

The Phase 2b RESPOND study enrolled women with FSAD and included women who had sexual dysfunctions in addition to FSAD.

Key Points: 
  • The Phase 2b RESPOND study enrolled women with FSAD and included women who had sexual dysfunctions in addition to FSAD.
  • In addition, only the Sildenafil Cream treatment group in this subset, and not the placebo group, demonstrated clinically meaningful improvement at the end of the 12-week period.
  • “The further analyses bolster our belief that Sildenafil Cream has the potential to successfully address the significant unmet need of arousal disorder.
  • The Phase 3 study design for Sildenafil Cream, including primary and secondary efficacy endpoints and inclusion/exclusion criteria for study participants, will be determined following discussions with the U.S. Food and Drug Administration (FDA), including the company’s end of Phase 2 meeting with the FDA.

20% of children have developmental delay. What does this mean for them, their families and the NDIS?

Retrieved on: 
Monday, August 28, 2023
Learning, Communication, Developmental disability, Education, Disability, ADHD, Diagnosis, Development of the human body, National Disability Insurance Scheme, Intellectual disability, Attention deficit hyperactivity disorder, Diagnostic and Statistical Manual of Mental Disorders, Child, Spectrum, Union of the Physically Impaired Against Segregation, Commonwealth, NDIS, Health, Protective factor, Residential care, Language industry, Toy, Vaccine, Nursing, Entertainment

Among the key issues identified was that 20% of Australian children experience learning difficulties, developmental concerns, developmental delay or are found to have disability.

Key Points: 
  • Among the key issues identified was that 20% of Australian children experience learning difficulties, developmental concerns, developmental delay or are found to have disability.
  • This presents another challenge: which government systems outside the NDIS will embrace the large number of children who need developmental support?

What is a developmental delay?

    • Many things can cause developmental delay.
    • Developmental delay is a term commonly used in clinical practice, but not included in official diagnostic manuals like the Diagnostic and Statistical Manual.
    • Developmental disabilities are included in official diagnostic manuals and include autism, attention deficit hyperactivity disorder (ADHD), intellectual disability, specific learning disorders, communication disorders and developmental coordination disorder.

Developmental delay and the NDIS


    The NDIS has a specific definition of developmental delay which encompasses three areas. Children are considered to have a developmental delay if their delay is:
    • Around 11% of all NDIS participants are classified as having a developmental delay.
    • There are also a significant number of children with developmental delay who are not within the NDIS.
    • While there is a general community view that developmental delay is an increasing issue in Australia, there is a lack of data tracking over time to understand if this view is accurate.

Supporting children with developmental delay

    • There has always been a large number of children experiencing developmental delay.
    • But the fragmentation across state/territory and Commonwealth health and disability systems has meant the true scale of children struggling with development has not been clear.
    • This figure is estimated to be a small proportion of the 20% of children who meet criteria for developmental delay.

Meeting children and families where they are

    • Its future thriving is highly dependent on how our community supports children with developmental delay.
    • Children with developmental delays receive supports within clinics, rather than in the natural settings in which they live and function every day.
    • Building capacity to support children with developmental delay in their everyday contexts – at home, in childcare, kindergartens or preschools, in the local community – will be crucial to ensuring children with developmental delay and their families thrive into later childhood.

FDA Approves First Oral Treatment for Postpartum Depression

Retrieved on: 
Saturday, August 5, 2023
PPD, Priority review, Pregnancy, Depression, Diarrhea, Center for Drug Evaluation and Research, Diagnostic and Statistical Manual of Mental Disorders, Birth, Deficit spending, Diagnosis, Urinary tract infection, Woman, Guilt, Mental, Sadness, Fatigue, Dizziness, Patient, Division, Risk, Child, Common, Grammatical mood, Psychiatry, Suicidal ideation, Research, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Behavior, Birth control, Nursing, Dietary supplement

SILVER SPRING, Md., Aug. 4, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults.

Key Points: 
  • SILVER SPRING, Md., Aug. 4, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults.
  • "Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child.
  • "Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings."
  • The efficacy of Zurzuvae for the treatment of PPD in adults was demonstrated in two randomized, double-blind, placebo-controlled, multicenter studies.

Daré Bioscience Announces Additional Positive Data from Exploratory Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women

Retrieved on: 
Tuesday, July 11, 2023
Cream, Desire, KOL, SST, Obstetrics, North American Menopause Society, Orgasm, International Society of Sculptors, Painters and Gravers, Diagnosis, FSAD, OBGYN, DSM-IV, NAMS, Woman, FACOG, Doctor of Philosophy, EDT, Trial of the century, NCMP, University Hospitals Cleveland Medical Center, Arousal, Medical director, Diagnostic and Statistical Manual of Mental Disorders, SAN, CCD, Gynaecology, Behavioral medicine, Erectile dysfunction, FDA, ITT, George Washington University, Female, Medical device, Management, Pharmaceutical industry

SAN DIEGO, July 11, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, and its collaborator Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced additional positive data from the exploratory Phase 2b RESPOND study evaluating topical Sildenafil Cream, 3.6% (Sildenafil Cream) as a treatment for female sexual arousal disorder (FSAD). Additional data reported today support continued clinical development of Sildenafil Cream to evaluate its potential to treat FSAD and/or female sexual interest/arousal disorder (FSIAD). Specifically, an exploratory endpoint regarding sexual desire demonstrated a statistically significant improvement from baseline to the 8-week mark after randomization in women in the intent to treat (ITT) population who used Sildenafil Cream compared to placebo, at P value = 0.022. The improvement in sexual desire at the 8-week mark compared to baseline in the Sildenafil Cream ITT group persisted through 12 weeks post-randomization (end of study).

Key Points: 
  • Additional data reported today support continued clinical development of Sildenafil Cream to evaluate its potential to treat FSAD and/or female sexual interest/arousal disorder (FSIAD).
  • The improvement in sexual desire at the 8-week mark compared to baseline in the Sildenafil Cream ITT group persisted through 12 weeks post-randomization (end of study).
  • “In this study, improvement was seen in arousal and orgasm, as well as sexual desire.
  • Daré will host a virtual Key Opinion Leader (KOL) webinar on Tuesday, July 11, 2023, at 4:30 p.m. EDT to review data from the exploratory Phase 2b RESPOND clinical study.

Lots of kids are 'late talkers'. Here's when to take action

Retrieved on: 
Friday, June 23, 2023
Academic achievement, Systematic review, Male, Communication, Speech, Developmental language disorder, Language disorder, Hearing loss, DLD, Spectrum, Parent, Diagnostic and Statistical Manual of Mental Disorders, Marie Cassidy, Diagnosis, DSM-IV codes, Research, Risk, History, Language, Disability studies, Mental, Literacy, Intellectual disability, Population, Child, Comprehension, Observation, Achievement Medal, Dyslexia, Mental health, Family, Environment, Otitis, Toy, Nursing, Dentistry, Language industry

As a speech pathologist, university lecturer and parent of young children, I often get asked a version of the following:

Key Points: 
  • As a speech pathologist, university lecturer and parent of young children, I often get asked a version of the following:
    My child isn’t talking yet.
  • Is that a problem?
  • But by the end of the conversation, I nearly always end up saying “it’s worth looking into”.

Who are late talkers?

    • Late talking is not an official diagnosis in the Diagnostic and Statistical Manual of Mental Disorders so clinical cut-offs vary.
    • The most common definition is that late talkers do not have 50 words and/or do not use two-word combinations by two years of age.
    • Children are generally assessed for late talking between two and three years via observation by a speech pathologist and parent reports.

Will my late talker grow out of it?

    • Firstly, late talkers may not fully catch up.
    • So, while a late talker may improve, they may face ongoing but perhaps more subtle difficulties at a later age, when language skills are critical to academic success and socialisation.
    • Such behaviours are more common among late talkers, likely because they lack the words to express feelings or wants.
    • This disorder occurs in at least one in five late talkers and can have substantial lifelong impacts on everyday functioning.

What are the risk factors for ongoing language problems?

    • While is no single predictor that allows us to know for sure which children will face ongoing language problems, potential factors include being born male, a family history of language disorders, socioeconomic status, low birth weight and vocabulary size (both speaking and understanding).
    • Disorders of speech and language cluster in families with genetic inheritance a significant factor.
    • Socioeconomic status and how parents interact with their children are risk factors found in research, but they are difficult to separate from the intergenerational impacts of language disorders.

Encouraging early talk


    Speech pathologists now take an active but cautious view: intervene rather than watch and wait. Intervention can be very helpful, consisting of training for parents. Techniques can include:
    • Importantly, a recent systematic review examined the results from 34 different intervention studies and found that 93% of them reported improvements in expressive vocabulary for late talkers.
    • If your child isn’t speaking as much as other children of the same age, it’s worth looking into it.

Opioid Use Disorder (OUD) Epidemiology Forecast Report, 2032: Focus on United States, Germany, Spain, Italy, France, United Kingdom, and Japan

Retrieved on: 
Tuesday, June 13, 2023
EU4, Failure, Prevalence, Diagnostic and Statistical Manual of Mental Disorders, Epidemiology, Opioid use disorder, Diagnosis, Quality of life, DSM-IV codes, OUD, Opioid, Fifth Edition, SUD, United Kingdom, DSM-5, Social Problems, Nursing, Cereal

This report delivers an in-depth understanding of the Opioid Use Disorder (OUD), historical and forecasted epidemiology in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Key Points: 
  • This report delivers an in-depth understanding of the Opioid Use Disorder (OUD), historical and forecasted epidemiology in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
  • The epidemiology forecast model of Opioid Use Disorder (OUD) for the 7MM is based on the use of the prevalence of Opioid Use Disorder (OUD) in the overall population to calculate the prevalent cases of Opioid Use Disorder (OUD).
  • The Opioid Use Disorder (OUD) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases of Opioid Use Disorder (OUD), gender-specific cases of Opioid Use Disorder (OUD), age-specific cases of Opioid Use Disorder (OUD), and severity-specific cases of Opioid Use Disorder (OUD), in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032.
  • It was observed that the 18-25 years age segment comprised the maximum number of cases of Opioid Use Disorder (OUD).

Erase PTSD Now Kicks Off Campaign to Change the Term PTSD (Post Traumatic Stress Disorder) to PTSI (Post-Traumatic Stress Injury)

Retrieved on: 
Monday, May 15, 2023
Survivor, American Psychiatric Association, Plague, Sympathetic nervous system, APA, Diagnosis, DSM-IV codes, Brain, Research, PTSI, Mental, Movement, Pain, Organization, Disorder, Post-traumatic stress disorder, Patient, Acute stress disorder, National Council, Anesthesiology, Diagnostic and Statistical Manual of Mental Disorders, Trauma, Chronic pain, PTSD, Migraine, Meat

Therefore, Erase PTSD Now is petitioning for a name change and kicking off a national campaign for PTSD to now be referred to as PTSI.

Key Points: 
  • Therefore, Erase PTSD Now is petitioning for a name change and kicking off a national campaign for PTSD to now be referred to as PTSI.
  • "At Erase PTSD Now, our goal is to restore individuals, as well as affected families and communities, to a pre-trauma state.
  • We believe that changing the name from PTSD to PTSI is an important step in achieving that goal," explains Coleen LaCosta, Executive Director of Erase PTSD Now.
  • Erase PTSD Now is calling on individuals, organizations, and communities to join the movement and support efforts to change PTSD to PTSI: an Injury that is treatable.

Talkspace Launches New Mental Health Conditions Library; a Free, One-Stop Resource for People Seeking Mental Health Information Online

Retrieved on: 
Wednesday, April 19, 2023
Health Technology, Health, Mental Health, Telemedicine, Virtual Medicine, Fifth Edition, DSM, Depression, Anxiety, Diagnostic and Statistical Manual of Mental Disorders, ADHD, Diagnosis, DSM-IV codes, Research, Risk, Mental health, Social media, Nursing, Talkspace

As more Americans continue to seek information about mental health conditions based online, Talkspace , the leading provider of virtual behavioral health services, today announced the launch of its new “ Mental Health Conditions Library .” The new site will be available to (both members and non-members of the Talkspace service) with free, clinically-evaluated, human-authored articles and information on a comprehensive range of mental health conditions.

Key Points: 
  • As more Americans continue to seek information about mental health conditions based online, Talkspace , the leading provider of virtual behavioral health services, today announced the launch of its new “ Mental Health Conditions Library .” The new site will be available to (both members and non-members of the Talkspace service) with free, clinically-evaluated, human-authored articles and information on a comprehensive range of mental health conditions.
  • The library will also provide information on available treatments related to those conditions.
  • The assessment will help guide individuals in evaluating if they should seek help from a licensed mental health professional to address their concerns.
  • All content in the Mental Health Conditions Library is authored by specialized writers and reviewed by a dedicated team of licensed, practicing Talkspace mental health clinicians.

Clinical Report: ACES Center of Excellence Onboarding Assessments Yield Best Client Outcomes

Retrieved on: 
Wednesday, February 22, 2023
Other Education, University, Primary, Secondary, Education, Training, Preschool, Mental Health, General Health, Children, Family, Science, Consumer, Other Science, Health, Research, Quality of life, Applied behavior analysis, Spectrum, ABA, ACES, Plan, Diagnostic and Statistical Manual of Mental Disorders, DSM-IV codes, COE, Multimedia, Diagnosis, Video game

View the full release here: https://www.businesswire.com/news/home/20230222005649/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230222005649/en/
    The ACES Center of Excellence (COE) is a time-proven, collective measure of five individual clinical parameters that are weighted and combined into a comprehensive and aligned Center of Excellence Index.
  • This simplified clinical weighting system allows for clinical differentiation, standard quality measurement among ABA clinics and excellence in clinical care.
  • Ashley Drag, ACES SVP of clinical services and innovation, said, “For the last 18 months, ACES’ Center of Excellence Scorecard has been used as the value-based standard of care by a national payor.
  • Editors’ Note: Please see the link below to video that demonstrates the ACES Center of Excellence assessment onboarding process to yield the best outcomes for ACES clients and their families.

Film About Campaign Leading the APA to Remove Homosexuality from Its Manual of Mental Illnesses, CURED, Named 2022 Recipient of Austen Riggs Erikson Prize for Excellence in Mental Health Media

Retrieved on: 
Monday, November 21, 2022
New York City Department of Health and Mental Hygiene, Trustee, Austen Riggs Center, Psychology, Diagnosis, APA, Empathy, LGBTQ, DSM, Erikson Institute, National Alliance, Partnership, Curriculum, Patient, Gay liberation, Education, National Action Network, Dignity, Homosexuality, Q&A, Classification, MD, American Psychiatric Association, National Alliance on Mental Illness, Advocacy, Diagnostic and Statistical Manual of Mental Disorders, Texas Association, Behavior, British Film Institute, Mental disorder, NYC Health + Hospitals, Pharmaceutical industry, Medicine, The New York Times, Research

The fight that led to this landmark decision is chronicled in the acclaimed documentary CURED, which the Austen Riggs Center has just awarded the 2022 Austen Riggs Erikson Prize for Excellence in Mental Health Media.

Key Points: 
  • The fight that led to this landmark decision is chronicled in the acclaimed documentary CURED, which the Austen Riggs Center has just awarded the 2022 Austen Riggs Erikson Prize for Excellence in Mental Health Media.
  • We are deeply grateful to the Austen Riggs Erikson Prize jury for this recognition, said Patrick Sammon, the co-director of CURED.
  • Our film chronicles a crucial shift in the relationship between the mental health profession and the LGBTQ+ communitya change that helped transform the social fabric of American society.
  • The prize is juried by a committee of Riggs clinicians and Trustees who considered more than 100 submissions in 2023.