Status:
COMPLETED
Measurement-Based Care Vs. Standard Care for Major Depressive Disorder
Lead Sponsor:
Pakistan Institute of Living and Learning
Collaborating Sponsors:
University of Toronto
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
Major depressive disorder (MDD) is one of the leading causes of disability worldwide, indicated as one of the two most disabling mental disorders by the Global Burden of Diseases, Injuries, and Risk F...
Detailed Description
Hypothesis: The rates of response and remission, and time to response and remission would be significantly shorter in the MBC group, without greater dropout rates and side effect burden, compared with...
Eligibility Criteria
Inclusion
- Adult outpatients age 18-65 of age
- Diagnosis of nonpsychotic MDD established by treating psychiatrists and confirmed by a checklist based on DSM-5 criteria at study entry
- Currently depressed with a score \>17 on the 17-item Hamilton Depression Rating (HDRS-17)
- Able to communicate effectively and give written informed consent
- Resident of the trial catchment area.
Exclusion
- 1\. Lifetime history of drug or alcohol dependence; 2. Diagnosis of bipolar, psychotic, obsessive-compulsive, or eating disorders confirmed with DSM-5 criteria 3. History of a lack of response or intolerance to either of the two protocol antidepressants (paroxetine and mirtazapine) 4. Currently pregnancy or breastfeeding; 5. Suicide attempts in the current depressive episode; 6. Any major medical condition contraindicating the use of the protocol antidepressants.
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Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05431374
Start Date
September 1 2022
End Date
January 30 2024
Last Update
December 10 2024
Active Locations (6)
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1
Bolan Medical Complex
Quetta, Balochistan, Pakistan
2
Services Hospital
Lahore, Punjab Province, Pakistan
3
Nishtar Hospital
Multan Khurd, Punjab Province, Pakistan
4
Benazir Bhutto Hospital
Rawalpindi, Punjab Province, Pakistan, 203393