Comparative Evaluation of Efficacy Tolerability and Safety of Combination of Oral Fluoxetine with Duloxetine Vs Combination of Oral Fluoxetine with Mirtazapine in Patients of Major Depressive Disorder A Prospective Randomized Double Blind Study

Depressive disorder (also known
as depression) is a common mental disorder. It involves a depressed mood
or loss of pleasure or interest in activities for long periods of time.

Women are more likely to have depression than men.

An estimated 3.8% of the population experience depression, including 5% of adults (4% among men and 6% among women), and 5.7% of adults older than 60 years. Approximately 280 million people in the world have depression . The clinical features of patients of depression are-

Emotional Symptoms - Diminished ability to experience pleasure • Loss of interest and pleasure in usual activities, hobbies, or work (anhedonia)

Physical Symptoms - Chronic fatigue

Appetite changes - variable

Cognitive Symptoms - Decreased concentration, poor memory

There are different patterns of depressive episodes including:

single episode depressive disorder, meaning the person’s first and only episode;

recurrent depressive disorder, meaning the person has a history of at least two depressive episodes; and

bipolar disorder, meaning that depressive episodes alternate with periods of manic symptoms.

AIMS and OBJECTIVES

 AIMS:-

 To compare the Efficacy, Tolerability and Safety of combination oral Fluoxetine with Duloxetine Vs combination of oral Fluoxetine with Mirtazapine in Patients of Major Depressive Disorder attending Psychiatry Out Patient Department at J.A. Group of Hospitals, Gajra Raja Medical College, Gwalior (M.P.).

 OBJECTIVES: Â·     PRIMARY:

(1). To compare the efficacy of the combination of oral fluoxetine with duloxetine versus oral fluoxetine with mirtazapine on patients of major depression.

(2). To find out the tolerability of the combination of oral fluoxetine with duloxetine versus oral fluoxetine with mirtazapine on patients of major depression.

 Â·     SECONDARY:(1). To monitor the safety of the combination of oral fluoxetine and duloxetine versus oral fluoxetine and mirtazapine in terms of adverse drug events.

METHODOLOGY•       On visit, after taking written informed consent and straining them through inclusion and exclusion criteria. The patients of Major Depression will  be enrolled for our study.

•       Our study was prospective, interventional, randomized and single-centred carried out at Department of psychiatry in outpatient department of a tertiary care hospital.

•       Details of total 80 Randomized patients (40 in each group) in 2 above mentioned groups will be taken in our proforma.

The patient’s evaluations of the treatments will be done on every month visit to the Psychiatry OPD.

•       The patient will be advised how to administer the drugs.

Socio-demographic details along with medication history will be taken and baseline assessment of depression will be done using Hamilton depression rating scale. Patients will be randomly assigned to receive either combination of Oral fluoxetine (20mg- 1 tab)-once a day in the morning after meal for 0-12 weeks and oral duloxetine (60mg- 2 tabs of 30-30mg)-twice a day after meals(12hrly) for 0-12 weeks or Combination of Oral fluoxetine (20mg-1tab)- once a day in the morning after meal for 0-12 weeks and oral mirtazapine(7.5mg-1tab)- at night before sleep for 0-12 weeks.

Follow-up will be done after 4 weeks, 8 weeks and 12 weeks interval after initiation of treatment using Hamilton depression rating scale.

 Ã˜ Inclusion criteria:o   Patients of Major depression of at least 2 weeks duration

o   Patients having mild to moderate depression as per ICD 10 criteria.

o   Patients between 18-45 years of age.

o   Patients who are willing to take part in the study with signed and written informed consent.

o   Patients can be of both male and female.

o   Patient must be medically stable.

 Ã˜ Exclusion criteria:o   Patients who are not willing to sign in after informed consent.

 o   Pregnant, breast feeding, child bearing age using contraception.

 o   Patient with severe depression

 o   Patient with a K/C/O any Autoimmune conditions like SLE, Myasthenia gravis, Vitiligo, Psoriasis, Rheumatoid arthritis etc.

 o   Patient receiving prior antidepressants within 3 months of enrollment.

 o   Patient with a history of Bipolar disorder.

 o   Patient with any hepatic and renal impairment.

o   Patient taking concomitant medications such as- NSAIDs and anticoagulants.

 o   Patient with suicidal tendencies interfering with compliance.