The science of Sad: understanding the causes of ‘winter depression’

The science of Sad

For many of us in the UK, the annual ritual of putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues as autumn well and truly beds in. This might be felt as a lack of energy, reduced enjoyment in activities and a need for more sleep than normal. But for around 6% of the UK population and between 2-8% of people in other higher latitude countries such as Canada, Denmark and Sweden, these symptoms are so severe that these people are unable to work or function normally. They suffer from a particular form of major depression, triggered by changes in the seasons, called seasonal affective disorder or Sad.

In addition to depressive episodes, Sad is characterised by various symptoms including chronic oversleeping and extreme carbohydrate cravings that lead to weight gain. As this is the opposite to major depressive disorder where patients suffer from disrupted sleep and loss of appetite, Sad has sometimes been mistakenly thought of as a “lighter” version of depression, but in reality it is simply a different version of the same illness. “People who truly have Sad are just as ill as people with major depressive disorder,” says Brenda McMahon, a psychiatry researcher at the University of Copenhagen. “They will have non-seasonal depressive episodes, but the seasonal trigger is the most common. However it’s important to remember that this condition is a spectrum and there are a lot more people who have what we call sub-syndromal Sad.”

Around 10-15% of the population has sub-syndromal Sad. These individuals struggle through autumn and winter and suffer from many of the same symptoms but they do not have clinical depression. And in the northern hemisphere, as many as one in three of us may suffer from “winter blues” where we feel flat or disinterested in things and regularly fatigued.

Putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues.

One theory for why this condition exists is related to evolution. Around 80% of Sad sufferers are women, particularly those in early adulthood. In older women, the prevalence of Sad goes down and some researchers believe that this pattern is linked to the behavioural cycles of our ancient ancestors. “Because it affects such a large proportion of the population in a mild to moderate form, a lot of people in the field do feel that Sad is a remnant from our past, relating to energy conservation,” says Robert Levitan, a professor at the University of Toronto. “Ten thousand years ago, during the ice age, this biological tendency to slow down during the wintertime was useful, especially for women of reproductive age because pregnancy is very energy-intensive. But now we have a 24-hour society, we’re expected to be active all the time and it’s a nuisance. However, as to why a small proportion of people experience it so severely that it’s completely disabling, we don’t know.”

There are a variety of biological systems thought to be involved, including some of the major neurotransmitter systems in the brain that are associated with motivation, energy and the organisation of our 24-hour circadian rhythms. “We know that dopamine and norepinephrine play critical roles in terms of how we wake up in the morning and how we energise the brain,” Levitan says. One particular hormone, melatonin, which controls our sleep and wake cycles, is thought to be “phase delayed” in people with severe Sad, meaning it is secreted at the wrong times of the day.

Another system of particular interest relates to serotonin, a neurotransmitter that regulates anxiety, happiness and mood. Increasing evidence from various imaging and rodent studies suggests that the serotonin system may be directly modulated by light. Natural sunlight comes in a variety of wavelengths, and it is particularly rich in light at the blue end of the spectrum. When cells in the retina, at the back of our eye, are hit by this blue light, they transmit a signal to a little hub in the brain called the suprachiasmatic nucleus that integrates different sensory inputs, controls our circadian rhythms, and is connected to another hub called the raphe nuclei in the brain stem, which is the origin of all serotonin neurons throughout the brain. When there is less light in the wintertime, this network is not activated enough. In especially susceptible individuals, levels of serotonin in the brain are reduced to such an extent that it increases the likelihood of a depressive episode.

The most popular treatments for Sad is bright-light therapy.

Read More: http://snip.ly/25gi4#https://www.theguardian.com/lifeandstyle/2017/oct/30/sad-winter-depression-seasonal-affective-disorder

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Complaints Handling, Adverse Event Reporting, and Recalls call for an integrated approach

Complaints Handling, Adverse Event Reporting, and Recalls4

Medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other. The new ISO version, the ISO 13485:2016, recognizes this fact. The disparate requirements of each regulatory system make it necessary for manufacturers to identify their roles, as well as the regulatory requirements for that role, and then incorporate them into their Quality Management System.

The various jurisdictions, however, deal with post-market device issues in diverse ways. Complaint management, Adverse event reporting and Recalls are three interlocking and interrelated processes that need to go into the QMS.

Corrective action and design changes, which are supporting QMS processes; also need to complement these three processes. And then, the regulatory requirements, which usually involve areas such as recordkeeping and reporting, also come in.

A course on how to implement an integrated QMS

Complaints Handling, Adverse Event Reporting, and Recalls3

GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing a highly educative and valuable learning session on these primary and secondary QMS processes and the way they need to be understood and implemented in relation to the US, EU, and Canadian regulations.

Dan O’Leary, who is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, which focuses on analytic skills and a systems approach to operations management, will be the Director of this two-day seminar. Dan brings more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.

Want to benefit from Dan’s rich experience and want to understand the way in which to implement an integrated QMS in which the various aspects of complaints, adverse reporting and recalls are built? Please register for this seminar by visiting Complaints Handling, Adverse Event Reporting, and Recalls call for an integrated approach. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Alignment with the FDA’s QMS

Complaints Handling, Adverse Event Reporting, and Recalls1

The extent of its alignment with the FDA’s Quality Management System (QMS) requirement is one of the highlights of the final version of the ISO 13485:2016 standard, which has now become available. The degree of alignment set out in 2016 version of 13485 may be significantly higher than that of the previous version of 2003; yet, there still do exist a few points at which it deviates from the FDA’s QMS. Companies that should comply with this standard have to keep this in mind.

Now that the ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), and the new EU Medical Device Regulation have been introduced; companies need to update their QMS and integrate all of the elements if their implementation has to be effective and compliant. At this two-day session, Dan will provide the tools that the participants will need for this.

Complaints Handling, Adverse Event Reporting, and Recalls
Upset man lost in thought having received bad news from his doctor

The agenda of this learning session will be the following:

  • The Regulatory Structure
  • FDA QSR
  • ISO 13485:2016 and regional variants
  • ISO 14971:2007 and regional variants
  • Implementing MDSAP
  • The EU Medical Device Regulation
  • Servicing
  • Identification of problems
  • Servicing data analysis
  • Input to the complaint process
  • Complaints

Identifying complaints

  • Evaluating complaints
  • Investigating complaints
  • Complaint data analysis
  • Input to the corrective action process
  • Input to the risk management process
  • Corrective Action
  • Developing the process
  • Analyzing product and process information
  • Determining subsequent actions
  • Input to the design process
  • Input to the risk management process
  • Design and Design Changes
  • Determining the need for a design change
  • Documenting design changes
  • Design change verification and validation
  • Input to the risk management process
  • Input to the pre-market submission process
  • Risk Management
  • ISO 14971:2007 and regional variants
  • Incorporating post-market information
  • Updating Pre-market Submissions
  • US – The 510(k) guidance
  • EU – Technical files and design dossiers
  • Canada – License changes
  • Adverse Event Reporting
  • US – MDR
  • EU – Vigilance Reports
  • Canada – Mandatory Problem Reporting
  • Recalls
  • US – Corrections and Removals
  • EU – Field Safety Corrective Actions
  • Canada – Recall.

 

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