The Effectiveness and Safety of Antiepileptic

Drugs (AED) in Managing Manic Phase of Bipolar

Disorder in Adults

Prepared by:

Supervisor:

Bipolar Disorder – manic-depressive

illness, brain disease causes people to have abnormal shift in mood, energy and ability to function

(Malaysian Mental Health Association, 2007)

Introduction

There are 4 main types of bipolar disorder: Bipolar I Disorder – patient has at least one episode of

mania or mixed mood and often will experience depression as well

Bipolar II Disorder – patient had at least one episode of depression and one period of hypomania

Cyclothymic Disorder – patient go back and forth between mild depression and slightly elevated mood

Bipolar Disorder Not Otherwise Specified (BPNOS) – patients do not fit into any types as mentioned

Rapid-cycling Bipolar Disorder – Patients with four or more episodes of mania and/or depression in a year

(Malaysian Mental Health Association, 2007)

Introduction

Mania – can be characterized by:

Grandiosity Decreased need for sleep Pressure to keep talking Flight of ideas Distractibility Increased activity Excessive involvement in pleasurable activities

with high potential for painful consequences. (Ostwald et al., 2007)

Introduction

Antiepileptic Drugs - drugs that are approved

and used primarily to treat people who have various kinds of seizures disorders.

Commonly prescribed to be used in patients with bipolar disorders

E.g. Sodium Valproate, Carbamazepine, Lamotrigine

(McDonagh et al., 2008)

Introduction

Antiepileptic drugs are initially used to treat seizures or epilepsy, however, they are also commonly used as mood stabilizer for bipolar disorder patients.

Valproate shows same efficacy as lithium in treating acute mania

(Pope et al., 1991; Freeman et al., 1992; Bowden et al., 1994).

The exact mechanism of action of antiepileptic drugs as mood stabilizer is still remain unclear.

(Jainer et al., 2011)

Problem Statement

Valproate, lamotrigine and other

antiepileptic drugs have an FDA warning that their use might increase risks of suicidal thoughts and behaviors.

Lack of conclusive studies on the effectiveness and safety of antiepileptic drugs in treatment of bipolar disorder.

(National Institute of Mental Health, 2008)

Problem Statement

Insufficient data on effectiveness and

safety of antiepileptic drugs in managing manic phase of bipolar disorder among the local populations

This study will give insight about the effectiveness and safety of antiepileptic drugs as mood stabilizer in bipolar disorder patients

Justification

General Objective:

To determine the effectiveness and safety of the use of antiepileptic drugs in managing manic phase of bipolar disorders

Specific Objectives:i. To identify the prescribing trend of treatment of

mania in patients with bipolar disorderii. To determine the effectiveness of antiepileptic

drugs in managing manic phase of bipolar disorderiii. To determine the safety of antiepileptic drugs in

managing bipolar disorder

Objective

Methodology

Study Design: Retrospective Medical Record Review

Sampling Method: Convenient sampling

Sample Size: approximately 100 patients

Site to conduct data collection: Psychiatry Clinic of Hospital Kuala Lumpur (HKL)

Outcome Measures:

Effectiveness of AED in managing bipolar disorder Patients’ Mental State Examination (MSE) &

improvement of symptoms / Brief Psychiatric Rating Scale (BPRS)

Safety of AED in bipolar disorder patients Full Blood Count (FBC) Liver Function Test (LFT) Other Adverse Effects Therapeutic Drug Monitoring (TDM)

Methodology

HKL Psychiatry Clinic

database Patient Screening

Patient Selection• Inclusion

Criteria• Exclusion

CriteriaRecord Office HKL

Data Collection Data Analysis

Methodology

Methodology

Inclusion Criteria: Adult patients

between 18-65 years old

Diagnosed with any type of bipolar disorder

Treated with at least one antiepileptic drug (AED)

Exclusion Criteria: Patients with

other neurologic and psychiatric illness

All data collected will be analyzed using SPSS

software. All categorical data are expressed as

percentage (%). Categorical data is analyzed using non-

parametric analysis, e.g. chi square test. Continuous data is expressed as mean

standard deviation, using parametric analysis, e.g. t-test.

Statistical Analysis

Effectiveness and safety of antiepileptic drugs

in bipolar disorder can be identified It might be a reference for the prescribers in

determining the first line drug therapy pattern in managing manic phase of bipolar disorder

Beneficial for counseling on the correct use of the antiepileptic drugs

Therapeutic Drug Monitoring (TDM) can be promoted

Impact of Study

Work Plan Jan Feb Mac Apr May Jun Jul Aug Sep Oct Nov Dec

Identify topic

of research

                       

Literature

Review

                       

Proposal

presentation

                       

Data

Collection

                       

Data Analysis                        

Write Up                        

Gantt Chart

References