Skip to content

To Compare Efficacy, Tolerability and Safety of Drug Combinations Used for treatment of Major Depressive Disorder

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/073098
Enrollment
80
Registered
2024-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F320- Major depressive disorder, singleepisode, mild

Interventions

Intervention1: 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 Control Interve

Sponsors

Dr Asmita Pandey
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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 Timepoint: Baseline 4 weeks 8 weeks 12 weeks

Secondary

MeasureTime frame
To monitor the safety of the combination of oral fluoxetine and duloxetine versus oral fluoxetine and mirtazapine in terms of adverse drug events.Timepoint: 0,4,8 and 12 weeks

Countries

India

Contacts

Public ContactDr Asmita Pandey

Gajra Raja Medical College

rajaryagrmc@gmail.com93000793791

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026