Evaluation of awareness of drug treatment, prescription pattern, adverse drug reactions and adherence in patients of Major Depressive Disorder

Title

Evaluation of awareness of drug treatment,prescription pattern, adverse drug reactions and adherence in patients of Major Depressive Disorder**.**

Primary Objective:

To assess the awareness of drugtreatment in patients.

Secondary Objectives:

 1.Tostudy the prescription pattern of the treatment of Major Depressive Disorder inPsychiatry OPD of Seth G.S. Medical College.

 2.Toassess the type, causality, severity, and preventability of ADRs in depressedpatients being treated with antidepressants.

3.To assess the adherence of patients toantidepressant medications

Methodology

Study Design: A a cross-sectional, observational, single-center, questionnaire-basedstudy

Study Site: Psychiatry OPDof Seth G.S. Medical College & KEMH, Mumbai.

Study Duration: 18 months afterEthics Committee approval including datacollection, analysis and report writing.

Sample size**:** 150 to 200 patients will be enrolled inthe study from January 2021 to June 2022.

Ethics: Permission ofthe Institutional Ethics committee will be taken beforebeginning the study.

Selection Criteria

Inclusion criteria for patients:

1.Allpatients with age 18-65 years, attending Psychiatry OPD for existing majorDepressive Disorder diagnosed as per the DSM-V Criteria.

2.Patients carrying treatment recordsprescribed at Psychiatry OPD of KEM hospital, containing antidepressant medication regimen for at least 3months.

ExclusionCriteria for patients:

1.Patientsadmitted in psychiatry IPD and emergency department

2. Newlydiagnosed and treatment-naive patients

3.Patientswith a history of substance dependence or abuse at the current visit.

4.Patientswith other Neurological disorders

5.Criticallyill patients requiring urgent attention for medical problems

6. Severely agitated patients or with activesuicidal ideation.

5. Variables to be measured

Primary Objective: Tostudy the awareness of drug treatment in MajorDepressive Disorder using an awareness questionnaire.

Secondary Objective :

1: To study theprescription pattern of treatment ofMajorDepressive Disorder in tertiary health care hospital

2: ADRs

1.Percentage of ADRs causallyrelated to antidepressanttreatment using the WHO- UMC

2.Percentage of ADRsclassified as mild, moderate, or severe, according to Hartwig-Siegel scale

3.Percentageof ADRs which are preventable, according to Schumock and Thorton scale

**3:**Adherence isassessed with the help of Morisky’s 8 item Medication Adherence Questionnaire.

STATISTICAL ANALYSIS

·       Categorical datawill be expressed as a percentage.

·       Continuousvariables will be presented as mean ± standard deviation (SD).

·       Variables of the prescription pattern will be analyzed using descriptive statistics and thelevel of drug utilization will be calculated using PDD/DDD ratio.

·       Pearson’scorrelation test will be used to assess the correlation between awareness andadherence to therapy.