NCT05431374Completed
Measurement-Based Care Vs. Standard Care for Major Depressive Disorder
A Randomized Controlled Trial of Measurement-Based Care Vs. Standard Care for Major Depressive Disorder in Pakistan
Source: ClinicalTrials.gov · Last updated 10 Dec 2024
Brief summary (registry, in English)
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 Factors Study (GBD) 2019 (Vos et al., 2020). Despite several effective pharmacological and psychosocial interventions available globally, only about one-third of depressed patients achieve remission (Xiao et al., 2021). There is a need to establish scalable clinical management practices which utilize biopsychosocial assessments, formulate a differential diagnosis, and provide evidence-based treatments for patients with MDD (Hong et al., 2021). While significant evidence for effectiveness of Measurement Based Care (MBC) is found in clinical settings from high and middle-income countries, assessments of MBC compared with usual care for the treatment of MDD are yet to be completed in low-resource settings like LMICs. The aim of this trial is to determine the efficacy and safety of MBC in patients with MDD in comparison with standard care in Pakistan. In order to reduce the variance found in treatment-as-usual and isolate the impact of MBC, standard care for this trial will limit medication choices to either paroxetine or mirtazapine.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 17 Jun 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 30 May 2023
- Lead sponsor
- Pakistan Institute of Living and Learning
- Diseases
- Depression
- NCT number
- NCT05431374
What you commit to
- Study type: Interventional
- Participants enrolled: 150
- From 1 Sept 2022 to the primary completion date, 30 May 2023
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- \-
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Civil Hospital Coordinator of this site? Confirm its status | Hyderābād | Pakistan | Unknown status |
| Civil Hospital Coordinator of this site? Confirm its status | Karachi | Pakistan | Unknown status |
| Services Hospital Coordinator of this site? Confirm its status | Lahore | Pakistan | Unknown status |
| Nishtar Hospital Coordinator of this site? Confirm its status | Multan Khurd | Pakistan | Unknown status |
| Bolan Medical Complex Coordinator of this site? Confirm its status | Quetta | Pakistan | Unknown status |
| Benazir Bhutto Hospital Coordinator of this site? Confirm its status | Rawalpindi | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.