A CLINICAL STUDY TO EVALUATE THE EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE IN REDUCING THE IRRITABILITY IN BIPOLAR I DISORDER – A STUDY PROTOCOL

Abstract

Objective: Bipolar Affective Disorder (BPAD), previously known as manic-depressive psychosis (MDP), characterized by unusual changes in mood, energy, activity levels and inability to carry out routine tasks. The symptoms were noticed in repeated (ie.atleast two) episodes of high or low mood at different times. Irritability is a psychological emotional response to a provoking stimulus, which can be seen both in manic and depressive episodes of bipolar disorder.This study aims to determine the effectivenessof individualized homoeopathic medicine in the reduction of irritability in patients diagnosed with Bipolar I Disorder. It also helps to understand the reduction in frequency of episodes and intensity of irritability in Bipolar I after using homoeopathic medicines.

Materials and Methods: The study design is Interventional Study-Before & After treatment without a control group. The patients who present with symptoms of irritability in Bipolar I disorder at Outpatient department, Inpatient Department and Peripheral Centers of NHRIMH Kottayam will be screened using screening form. The cases fulfilling inclusion and exclusion criteria’s will be enrolled in the study after approval of Psychiatrist and patients consent. The trial sample size is calculated as 35 considering 15% dropouts. The period of enrollment and follow up shall be for 1 ½ years which includes 6 months enrollment and 1 year follow up. Cases will be assessed at the Baseline with Born Steiner Irritability scale (BSIS) to measure the irritability, and Scale for the Assessment of Episodes in Bipolar Disorder (SAEBD) is used for the intensity of symptoms of bipolar disorder. Each case will be reviewed at every 4 weeks interval with the Born Steiner Irritability scale (BSIS) till the conclusion of the study. SAEBD will be used to assess the cases at the Baseline and every three months till the conclusion of the study. The outcome of the study will be assessed by difference of scores obtained during baseline and end in   BSIS scale, and SAEBD scale.

Discussion and Conclusion: Bipolar disorder stands out as one of the prominent conditions among the mental disorders. A recent study shows there is increase in diagnosis of BPAD at early onset which in turn result in poor prognosis. The need of early diagnosis and timely management call for immediate attention.  Irritability is a symptom of both manic and depressive episodes of Bipolar 1 disorder. This clinical study provides a novel impression in the assessment and reduction of irritability in BPAD-I. It is also expected that the study helps in understanding the irritability which forms main precipitating factor in majority of cases and believed to reduce the intensity of irritability and frequency of episodes in Bipolar I disorder.

KEY WORDS: BPAD- 1, Irritability, Single arm clinical study, Homoeopathy