Depression: Therapeutic area expertise

Depression clinical trials

Sadness is a common emotion. It’s a ‘customary’ reaction to loss, failure, rejection; all of which are inevitable in everyone’s everyday routine existence. But staying sad for too long with inability to snap out of it is not justifiable. Depression trials for INDs require in depth understanding of this disorder, simplifying complex concepts and assuring complete patient focus by non-medical staff that is responsible for varied trial activities. In depth cognizance of the disorder: etiology, presenting features, diagnosis, assessment and management is important. Each one cannot be a psychiatrist, but each one can enhance understanding of concepts of illnesses in psychiatry to assure smooth functioning of the psychiatry drug trial.

Understanding depression

Depression is not simply a state of ‘mood’. It becomes a part of life of the depressed person. Slowed speed of thought, inability to make brisk decisions, not wanting to talk to people; these are the initial presenting features of pathological depression (making it different from ‘just a bad mood’). Depression may mask itself and present contrarily to what is expected of it. Sometimes one may experience ‘atypical’ symptoms like overeating, excessive sleeping, anger (instead of sadness), restlessness, agitation; all of which never arouse the suspicion of ‘depression’. Mood changes during menstruation, chocolate craving, anger outbursts, seasonal mood switches are all masks that depression garbs itself in. It may occur in bouts for short periods of time (recurrent brief depression), may be seen monthly in females prior to the menses (pre-menstrual dysphoria), may follow a seasonal pattern of coming up in the summer or winter months (seasonal depression), or may be continuous and last for years together (chronic depression). Knowing this helps in understanding trial protocols.

Clinical trial protocols

Measurement of social behavior and subjective feelings has shown that depression is one of the most disabling and distressing medical illnesses, causing significant disability. The continuous mental pain seriously influences the quality of life and the person rightly feels that life is really not worth living. The risk for suicide is the highest in depression compared to all other disorders. The quality of life is an indicator of therapeutic response. These variables are typically assessed as per protocol. A detailed understanding of the same helps trial staff offer their best for optimal functioning of the trial.

Studying depression

Baseline knowledge of depression:

  • Multiple modes of presentation
  • Diversity in the symptomatology
  • Bio-psycho-social contributions
  • Neurotransmitter imbalances
  • Seasonal and episodic variations
  • Attaining/ maintaining remission

Depressive disorder training

The MINDFRAMES therapeutic area expertise in depression and the previous training with Pfizer Ltd. and Janssen Cilag Ltd. have encompassed detailed explanation of core illness characteristics.

  • Introduction to depression types
  • Sad moods and their changes
  • Clinical symptom presentation
  • Diagnostic criteria DSM and ICD
  • Different assessment tools
  • Diagnostic interview process
  • Rating instruments in depression
  • Source documentation and history
  • Progress report and prognosis
  • Site monitoring tools and tips
  • Anticipated adverse events
  • Expected realistic outcomes
  • Understanding trial dropouts
  • Communicating with investigators