Status:
COMPLETED
Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia
Lead Sponsor:
National Institute of Mental Health, Dhaka
Collaborating Sponsors:
Sun Pharmaceutical Industries Limited
Conditions:
Major Depressive Disorder With Insomnia
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
This will be a single center, prospective, open label, quasi-experimental pre-post intervention trial in major depressive disorder (MDD) patients with insomnia. The main objectives are i. to assess e...
Detailed Description
Background: Mirtazapine is an atypical antidepressant acts by increasing noradrenergic and serotonergic neurotransmission. It inhibits presynaptic adrenergic alpha-2 receptor along with inhibition of ...
Eligibility Criteria
Inclusion
- Age 18-60 years.
- Diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for MDD.
- A ≥20 total score on the 17-item Hamilton depression rating scale (HDRS).
- A ≥15 total score on the 7-item Insomnia Severity Index (ISI).
- Considered to require antidepressant treatment based on the judgment of the consulting psychiatrist.
- For women - willing to abstain from conception or willing to use modern method of contraception (she or her partner) during trial period.
Exclusion
- History of use of mirtazapine in the last 3 months period.
- Pregnant or breastfeeding mother.
- At significant risk for suicide.
- Diagnosed with a primary condition including dementia as well as bipolar, obsessive-compulsive, or eating disorders, schizophrenia, or alcohol or substance dependence except for tobacco dependence.
- Experiencing any medical conditions judged to render the patient ineligible to participate in the study.
Key Trial Info
Start Date :
May 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT05978219
Start Date
May 25 2023
End Date
March 1 2024
Last Update
April 2 2024
Active Locations (1)
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1
National Institute of Mental Health
Dhaka, Bangladesh, 1207