An interventional study of Measurement Based Care (MBC) and Control/Standard-care in Major Depressive Disorder, sponsored by Pakistan Institute of Living and Learning. Completed at 6 sites in Pakistan. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by Pakistan Institute of Living and Learning · Not applicable, Interventional, and Treatment
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.
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 the standard treatment group.
Study design and setting This will be a multi-centre, with assessors blind to protocol and treatment group, parallel arm, randomized controlled trial (RCT). The study is a direct replication of a study conducted by Gou et al. (2015) in China.
Participants Participants will be recruited from psychiatric units of teaching and non-teaching hospitals in 6 centres: Karachi (population 23 million), Lahore (population 10 million), Rawalpindi (population 3 million), Hyderabad (population 2 million) and Quetta (population 1 million) and Multan (1.8 million).
Sample size The sample size of 120 participants for this exploratory trial is based on the study conducted by Guo et al.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 150 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Pakistan Institute of Living and Learning is the lead sponsor of 59 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
-
patients in the MBC group will receive treatment according to a schedule that includes individualized starting dosages, dosage adjustment, and medication changes to minimize side effects, maximize safety, and optimize the therapeutic benefit for each patient.
Other: Measurement Based Care (MBC)
Local medical, psychiatric and family medicine services provide routine care according to their clinical judgment and available resources. Standard-care will be ascertained by the participant's treating physician. Research staff will record the nature and intensity of standard-care delivered to each participant. In current practice, MDD patients are not routinely referred for any psychological therapies in Pakistan. Standard-care in Pakistan largely comprises of pharmacotherapy.
Other: Control/Standard-care
Patients in both groups will receive either open-label paroxetine (10-40mg/day) or open-label mirtazapine (7.5-45mg/day), within the therapeutic dosage range recommended by the US Food and Drug Authority (Paxil -Highlights of Prescribing Medication, 2022; Remeron -Highlights of Prescribing Medication, 2022). Paroxetine, a selective serotonin reuptake inhibitor, is chosen because it has been one of the most commonly prescribed antidepressants, and mirtazapine, an alpha-2 antagonist, is chosen because it has a different mechanism of action. The treating psychiatrists will decide which of the antidepressants and dosages to prescribe, as long as they were within the study's recommended dosage ranges. patients in the MBC group will receive treatment according to a schedule that includes individualized starting dosages, dosage adjustment, and medication changes to minimize side effects, maximize safety, and optimize the therapeutic benefit for each patient.
Local medical, psychiatric and family medicine services provide routine care according to their clinical judgment and available resources. Standard-care will be ascertained by the participant's treating physician. Research staff will record the nature and intensity of standard-care delivered to each participant. In current practice, MDD patients are not routinely referred for any psychological therapies in Pakistan. Standard-care in Pakistan largely comprises of pharmacotherapy.
Hamilton Depression Rating (HDRS-17) - Time to Response
is a 17-item instrument that was designed to measure frequency and intensity of depressive symptoms in individuals with major depressive disorder. Ratings are made using either a five- or a three-point scale, yielding total scores from zero to 61. Response will be defined as a decrease of 50% from the baseline HDRS-17 score.
Time frame: Time from baseline to response (in weeks) (assessed upto 24 weeks).
Hamilton Depression Rating (HDRS-17) - Time to Remission
is a 17-item instrument that was designed to measure frequency and intensity of depressive symptoms in individuals with major depressive disorder. Ratings are made using either a five- or a three-point scale, yielding total scores from zero to 61. Remission as a HDRS-17 score\<7
Time frame: Time from baseline to remission (in weeks) (assessed upto 24 weeks)
Hamilton Depression Rating (HDRS-17) - Severity
is a 17-item instrument that was designed to measure frequency and intensity of depressive symptoms in individuals with major depressive disorder. Ratings are made using either a five- or a three-point scale, yielding total scores from zero to 61. Higher scores indicate higher severity.
Time frame: Change in scores from baseline to 3-month and 6-month follow up
Adverse Effect Checklist
This checklist includes some common adverse effects of antidepressant medications.
Time frame: Rates of adverse effects from baseline to 6-month follow up
All-cause discontinuation
Discontinuation from participation in the study.
Time frame: Time from baseline to all-cause discontinuation of antidepressant medication (assessed upto 24 weeks)
Plan to share: No — Only anonymized data will be shared with researchers
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pakistan Institute of Living and Learning