| CTRI Number |
CTRI/2024/08/073098 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Compare Efficacy, Tolerability and Safety of Drug Combinations Used for treatment of Major Depressive Disorder |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asmita Pandey |
| Designation |
Post-Graduate Resident |
| Affiliation |
Gajra Raja Medical College |
| Address |
Department of Pharmacology, Gajra Raja Medical College, Veer Savarkar Marg, Lashkar,
Gwalior- 474009
Madhya Pradesh
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9424844230 |
| Fax |
|
| Email |
asmitapandey5196@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raj Kumar Arya |
| Designation |
Professor and Head of the Department |
| Affiliation |
Gajra Raja Medical College |
| Address |
Gajra Raja Medical College,
Department of Pharmacology,
Gwalior- 474009
Madhya Pradesh
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
93000793791 |
| Fax |
|
| Email |
rajaryagrmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asmita Pandey |
| Designation |
Post Graduate Resident |
| Affiliation |
Gajra Raja Medical College |
| Address |
Gajra Raja Medical College,
Department of Pharmacology,
Gwalior- 474009
Madhya Pradesh
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
09424844230 |
| Fax |
|
| Email |
asmitapandey5196@gmail.com |
|
|
Source of Monetary or Material Support
|
| JA GROUP OF HOSPITALS, GAJRA RAJA MEDICAL COLLEGE, VEER SAVARKAR MARG, LASHKAR GWALIOR, MADHYA PRADESH-474009, INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Asmita Pandey |
| Address |
Gajra Raja Medical College,
Department of Pharmacology,
Gwalior- 474009
Madhya Pradesh |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr ASMITA PANDEY |
JA GROUP OF HOSPITALS GAJRA RAJA MEDICAL COLLEGE |
DEPARTMENT OF PSYCHIATRY
BLOCK-C
Department of Pharmacology,
GAJRA RAJA MEDICAL COLLEGE
Madhya Pradesh
Gwalior
MADHYA PRADESH |
9424844230
asmitapandey5196@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) GAJRA RAJA MEDICAL COLLEGE, GWALIOR, M.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fluoxetine, Duloxetine |
Oral Fluoxetine 20MG once daily after lunch for a duration of 3 months
, Oral Duloxetine 30MG twice daily after meal 12HOURLY for a duration of 3 months |
| Intervention |
Fluoxetine, Mirtazapine |
Oral Fluoxetine 20mg once daily after lunch for a duration of 3 months
, Oral Mirtazapine 7.5mg once daily before bed for a duration of 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of Major Depression of at least 2 weeks duration.
2. Patients having mild to moderate depression as per ICD 10 criteria.
3. Patients between 18-45 years.
4. Patients who are willing to take part in the study with signed and written informed consent.
5. Patients can be both male and female.
6. Patients must be medically stable. |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of the combination of oral fluoxetine with duloxetine versus oral fluoxetine with mirtazapine on patients of major depression the assessment will be done using Hamilton Depression Rating Scale
|
Baseline 4 weeks 8 weeks 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety of the combination of oral fluoxetine and duloxetine versus oral fluoxetine and mirtazapine in terms of adverse drug events. |
0,4,8 and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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:
·
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.
·
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.
Ø 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.
Ø 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.
|