Bipolar: Therapeutic area expertise

Bipolar disorder clinical trials

Understanding bipolar disorder has been a march from dogmatism, mysticism, and scientific ambiguity, to a search for certainty. Psychiatry therapeutic area demands an understanding of this disorder, simplifying complex concepts and assuring complete patient focus by non-medical staff that is responsible for varied activities in a clinical trial. 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.

Bipolar disorder and reality

Mania is an extreme of positive emotion, which does not at all match the manic person’s background situation. The positivity and optimism is a façade that is usually put up to mask some hidden trauma or setback. It is psychodynamically best-explained s a compensatory mechanism for combatting disappointment. The conscious mind fails to accept the loss and tries to restitute it by expressing a disguised emotion that is diametrically opposite to the real mindful one. And this façade constitutes the disorder that needs to be managed.

Understanding bipolarity

Mania is attributable to genetic factors that lead to chemical changes in the brain. It has also been associated with traits of inferiority, which the individual’s depressed psyche tends to overcorrect by grandiosity. In genetically primed individuals, negative life events may bring about depression or mania. The high of mania in 100% of cases alternates with lows of depression, which is why it is commonly known as bipolar disorder. Bipolar variants ought to be differentiated from each other in order to study the impact of INDs in specific states.

Clinical trial protocols

Bipolar upsets the socio-occupational setup of the person. Both phases; depression as well as mania, are tormenting owing to loss of rationality and reason. Disability associated with bipolar disorder is very high. The quality of life is an indicator of therapeutic response. The productivity in the interim period between swings is usual and the person can lead a normal life. 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.

Signs of Bipolarity

Prototypal knowledge of bipolar:

  • First presentation heterogeneity
  • Compensatory mood correction
  • Process of cycling and swinging
  • Neurotransmitter imbalances
  • Seasonal and episodic variations
  • Attaining/ maintaining remission

Bipolar disorder training

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

  • Introduction to bipolar disorder
  • Awareness of mood and cyclicity
  • Clinical symptom presentation
  • Diagnostic criteria DSM and ICD
  • Different assessment tools
  • Diagnostic interview process
  • Rating scales in bipolar disorder
  • 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