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Journal of Drug Delivery and Therapeutics

Open Access to Pharmaceutical and Medical Research

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Open Access  Full Text Article                                                                                                                                                                            Research Article 

Comparison and Assessment of Prescribing Pattern of Psychotropic Agents in Bipolar Affective Disorder with Mania and Depression 

Ajmal Shajahan¹ , Angel Princy K R¹ , Mahima M S¹ , K Muhammed Safwan¹ , Fathima Jaleela M.A²* 

¹ Doctor of Pharmacy Intern, Indiana Hospital and Heart Institute, Pumpwell, Mangalore, Karnataka

² Associate Professor, Department of Pharmacy Practice, Shree Devi College Of Pharmacy, Kenjar Airport Road, Dakshina Kannada, Mangalore, Karnataka – 574142

INTRODUCTION

Bipolar disorder is a chronic condition characterized by variations in mood, energy, and behavior. It is one of the leading causes of disability among adolescents, causing cognitive and functional impairments as well as an increased risk of suicide.¹ According to studies, patients with bipolar disorder spend more time in depressive episodes and recover more slowly than in a manic phase.² Suicide is more likely to occur during mixed or depressed mood states.³

STAGES OF BIPOLAR DISORDER

Epidemiology – The lifetime prevalence of bipolar disorder is 1.3 to 1.6%. The disease has a two to three times higher mortality rate than the general population.⁸There is no direct connection between race/ethnicity, socioeconomic status, and location (e.g., rural vs. urban).⁹

Etiology- The cause of the bipolar disorder is unknown. Early life trauma, life events, alcohol consumption, and other substance use can influence the disease's onset and progression.¹⁰

The course of the illness- 

Bipolar disorder is commonly misdiagnosed because of its variable course and mood episodes.^10,11 .Females are more likely to have mixed states, depressive episodes, and rapid cycling compared to men. Males are more likely to develop manic episodes.¹²

Clinical presentation – 

There are four types of mood episodes in bipolar disorder: mania, hypomania, depression, and mixed episodes.¹³

Depressive episodes- Severe lack of interest in activities, weight loss or gain, trouble sleep problems, feeling hopeless.¹⁴ The risk of suicide is significantly increased.¹⁵

Manic episodes -The mood is characterized as feeling high or optimistic, extremely irritable, and the resulting overactivity is typically unproductive.¹⁶

Hypomania – It is a milder type of mania. Symptoms are similar to mood disturbances caused by cocaine or antidepressants. No significant reduction in social or occupational activity. Delusions and hallucinations are absent.¹⁰

Mixed episodes- They are described as having both depressive and hypomanic or manic symptoms or a rapid alternation of the three symptomatic forms.⁵

TREATMENT OF BIPOLAR DISORDER 

The assessment may cover the history of the number of previous episodes, type of the first episode, the polarity of illness, duration and severity of episodes, presence or absence of suicidal behavior, seasonal variation in the onset of symptoms, presence of rapid cycling and features of ultra-rapid cycling.¹⁷

Psychosocial treatment for bipolar disorder:

Bipolar disorder is characterized by a significant psychosocial impairment, low rates of medication adherence, interpersonal dysfunction, and cognitive impairment. Each of these domains is adequately addressed by psychotherapeutic interventions, particularly when delivered in combination with pharmacotherapy.¹⁸

Electroconvulsive Therapy [ECT] is a medical procedure for the treatment of severe psychiatric disorders. Its primary purpose is to rapidly relieve psychiatric symptoms. It is available for patients who are pregnant, unresponsive to more standard treatments, or unable to tolerate first-line treatments. For patients who are manic or depressed during the first trimester of pregnancy, ECT is usually the safest and most effective treatment.¹⁹

METHODOLOGY

A prospective observational study was carried out on the inpatients of the concerned department for a period of six months at Yenepoya Medical College and Hospital, Mangalore. A patient information sheet was given to the patients, and informed consent was obtained from the patient and/ or the caregivers. About 30 patients were selected for the study based on inclusion and exclusion criteria. Patient data were collected using a patient data collection form which included the demographic details, mental status examination, diagnosis, and medications. Assessment of prescription patterns was done by analyzing the prescription of 30 patients.

STUDY DESIGN

This study was a hospital-based prospective and observational study.

STUDY CENTRE

The study was conducted in the department of Psychiatry ward, Yenepoya Medical College, Derlakatte, Mangalore.

STUDY DURATION

The study was carried out for a period of 6 months.

SAMPLE SIZE

By convenient sampling, the sample size was found to be 30.

STUDY CRITERIA 

The study will be carried out by considering the following criteria:

Inclusion criteria: 

• Subjects diagnosed with Bipolar Affective Disorder (BPAD ICD-10 F 31) with Mania and Bipolar Affective Disorder with Depression at the Psychiatry department who are willing to give written informed consent for the participation.
• Availability of caregivers. 
• Patients who are 18 years old and above of either sex. 

Exclusion criteria: 

• Patients/Caregivers are unwilling to give the consent form. 
• Pediatric patients 
• All pregnant and lactating women. 

DATA COLLECTION TOOLS:

Patient consent form: Consent was collected either from the patient or bystander using a self-designed consent form. The consent form was made in two languages: English and Kannada.

Patient data collection form:

Data was collected using a self-designed data collection form, which consists of details like patient demographics, mental status examination, diagnosis, drug therapy, and other relevant information. 

ETHICAL APPROVAL: The study was approved by the Institutional Ethics Committee of Yenepoya Medical College and Hospital, Mangalore.

STATISTICAL ANALYSIS:

Statistical analysis was done using Statistical Package for Social Sciences (SPSS) Version 22 and Microsoft Excel version 13. Statistical hypothesis testing uses paired t-test to assess the existence of a statistically significant association between the variables tested. We considered the 5% level of significance as statistically significant. Descriptive statistics of the explanatory and outcome variables were calculated by mean, standard deviation, frequency, and charts.

RESULTS

Age-Wise Distribution 

Table 1.1: Frequency and percentage distribution of samples according to age.

Figure 1.1: Bar diagram representing percentage distribution of samples according to age.

Gender-Wise Distribution of Patients 

Table 1.2: Frequency and percentage distribution of samples according to sex   N=30

Figure 1.2: Percentage distribution of samples with bipolar depression and mania according to gender.

Family History Wise Distribution 

Table 1.3: Frequency and percentage distribution of samples according to family history   N=30

Figure 1.3: Doughnut representing percentage distribution of samples according to family history

According to Suicidal Thoughts 

Table 1.4: Frequency and percentage distribution of samples according to suicidal thought N=30

Figure 1.4: Percentage distribution of samples with bipolar depression and mania according to suicidal thoughts

According to the Distribution of Drugs Prescribed 

Table 1.5.a: Frequency and percentage distribution of drugs prescribed for patients with bipolar mania and depression.

N=30

Figure 1.5.a: Percentage distribution of drugs prescribed for patients with bipolar mania and depression.

According to the Type of Therapy 

Table 1.5.b: Frequency and percentage distribution of samples according to the type of therapy N= 30

Figure 1.5.b: Bar diagram representing frequency and percentage distribution of samples according to the type of therapy

 According to Drug Combination 

Table 1.5.c: Frequency and percentage distribution of samples according to the drug combination  N= 30

Bipolar Depression Drug Combination:

Fig 1.5.c.i: Bar diagram representing frequency and percentage distribution of samples according to drug combination (bipolar depression)

Bipolar Mania Drug Combination:

Fig.1.5.c.ii: Bar diagram representing frequency and percentage distribution of samples according to drug combination(bipolar mania)

According to Treatment Modality 

Table 1.6: Frequency and percentage distribution of samples according to treatment modality   N=30 

Figure 1.6: Cylindrical diagram representing percentage distribution of samples according to treatment modality

DISCUSSION

This study was carried out with the aim of comparing and assess the prescribing pattern of psychotropic agents in bipolar mania and bipolar depression in a tertiary care teaching hospital. In a sample group of 30, patients were classified into different age groups that are 18-35, 36-50, and above 50, and the number of patients in each group was observed as 8(26.7%), 14(46.7%) and 8(26.7%) respectively. The majority of patients were present in the 36-50 age group, which was supported by Levine J et al.²⁰ In bipolar depression, female subjects 8(53.3%) predominated over male subjects 7(46.7%). In bipolar mania, male subjects 12(80%) predominated over female subjects 3(20%). This indicates that males are usually more present with manic episodes than females, and females are more present with depressive episodes than males. The study was supported by Vega p et al.²¹

Nearly 19(63.3%) patients had a significant family history, and 11(36.7%) patients had a non-significant family history of bipolar disorder. Patients with a significant family history are at great risk, and this is common in bipolar disorder, supported by Benazzi F et al.²² In patients diagnosed with bipolar depression, 8(53.35%)patients had death wishes,1(6.7%)patient attempted suicide, and 1(6.7%) patient had both attempted suicide and death wishes. None of the patients diagnosed with bipolar mania had death wishes or suicide attempts. The polarity of the current mood episode is one of the most significant determinants of suicidal activity in bipolar disorder: depressive episodes carry the greatest risk, whereas suicidal behavior is uncommon in (euphoric) mania. The study was supported by Dome P et al.²³ In the study, 8(26.7%) patients had stressful life events which can trigger bipolar disorder, and 22(73.3%) didn't have any stressful life events. The study was supported by Johnson SL et al.²⁴ In bipolar depression, 7(46.7%) patients were treated with dual therapy, and 8(53.3%) people were treated with polytherapy. In bipolar mania, 6(40%) patients were treated with dual therapy, and 9(60%) of patients were treated with polytherapy. None of the patients were treated with monotherapy. Combination therapy was preferred over monotherapy in order to effectively control mood symptoms and reduce relapse. The study was supported by Lin D et al.²⁵ The most commonly prescribed drug combination was Mood stabilizer + Antipsychotic + Benzodiazepine combination, 5(33.3%) in bipolar depression and 9(60.0%) in bipolar mania, which is supported by Trivedi Jk et al.²⁶ The most commonly prescribed mood stabilizer was valproic acid 7(46.7%) in bipolar depression and 14(93.3%) in bipolar mania, followed by Lithium 6(40%) and 1(6.7%), oxcarbazepine to 3(20%) patients. A potential objective reason for the decrease in the use of lithium might be a more delayed antimanic effect, which is supported by Walpoth-Niederwanger M et al.²⁷ The most commonly prescribed Benzodiazepine in bipolar depression was Clonazepam 6(40%), followed by lorazepam 5(33.3%) and diazepam 2(13.3%). In bipolar mania, lorazepam 9(60%) was prescribed the most, followed by Clonazepam 2(13.3%) and diazepam 1(6.7%). Among antipsychotics, Second generation antipsychotics such as olanzapine and quetiapine were both prescribed to 6(40%) in bipolar depression, and 8(53.3%) in bipolar mania commonly prescribed, followed by lurasidone 2(13.3%). The First generation of Antipsychotic haloperidol was prescribed to 1(6.7%) bipolar depressive patients and 10(66.7%) bipolar manic patients. Among antidepressants, escitalopram was prescribed to 3(20%) patients, followed by fluoxetine which was given to 1(6.7%) patient. Antidepressants are prescribed with mood stabilizer because they can induce mania, and it is not given in the manic phase, which was supported by Lim Pz et al.²⁸ The results indicate that patients spent ever-increasing amounts on psychotropic medication, in particular second-generation antipsychotics and valproic acid, supported by Hayesh J et al.²⁹ There are three treatment modalities for bipolar disorder, i.e., psychotropic drug therapy, psychosocial therapy, and ECT. Psychotropic drugs were given to all patients, psychosocial therapy was given to 24 (80%) patients, and ECT was given to 2(6.7%)patients. ECT should be considered if the risk to self or others is high, psychotic features are present, or there has been a previous response to ECT or in severe cases. A very small percentage of patients received electroconvulsive therapy (ECT), despite its well-documented efficacy in the treatment of both phases of the disorder. The study was supported by Lim pz et al.²⁸

CONCLUSION

From the present study, it may be concluded that valproic acid is the most prescribed drug in both bipolar depression and bipolar mania. Combination therapy was used in the treatment to effectively control mood episodes, and the most commonly prescribed combination therapy was mood stabilizer with Benzodiazepine and antipsychotic. When compared to the use of first generation antipsychotics,the use of second generation antipsychotic increased. The clinicians do not fully comply with all recommendations as it is meant to advise rather than mandate a particular type of treatment and the treatment is individualized.

ACKNOWLEDGEMENT:

The authors of the study are heartily thankful for the guidance and support received from all the members who contributed to this project, it was vital for the success of the project. They would also like to express their sincere thanks to all the study participants.

Author Contributions:

Author's role in study concept and design, acquisition of subjects and/or data, analysis and interpretation of data, and preparation of the manuscript.

Study concept: Dr.Ajmal Shajahan, Dr.Angel Princy K R, Dr.K Muhammed Safwan, Dr.Mahima M.S, Dr.Fathima Jaleela.M.A 

Acquisition of subjects and/or data: Dr.Ajmal Shajahan, Dr.Angel Princy K R, Dr.K Muhammed Safwan, Dr.Mahima M.S, Dr.Fathima Jaleela.M.A

Interpretation of data: Dr.Ajmal Shajahan, Dr.Angel Princy K R,Dr. K Muhammed Safwan, Dr.Mahima M.S, Dr.Fathima Jaleela.M.A

Preparation of Manuscript: Dr.Ajmal Shajahan, Dr.Angel Princy K R,Dr. K Muhammed Safwan, Dr.Mahima M.S, Dr.Fathima Jaleela.M.A

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Source of funding: The author(s) received no financial support for the research, authorship, or publication of this article.

Available data and material:

All the information related to the study is embedded within the manuscript.

Conflict of Interest:

The authors declare no conflict of interest.

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