Measurement-Based Care Vs. Standard Care for Major Depressive Disorder

NCT05431374 | Completed DMC

• 2 other identifiers: MBC-DepressionDepression
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 6

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 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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Measurement Based Care MBC; Pakistan

Outcome Measures

Primary Outcomes (2)

• 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 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 from baseline to remission (in weeks) (assessed upto 24 weeks)

Secondary Outcomes (3)

• Hamilton Depression Rating (HDRS-17) - Severity

  Change in scores from baseline to 3-month and 6-month follow up

• Adverse Effect Checklist

  Rates of adverse effects from baseline to 6-month follow up

• All-cause discontinuation

  Time from baseline to all-cause discontinuation of antidepressant medication (assessed upto 24 weeks)

Study Arms (2)

Measurement Based Care MBC

EXPERIMENTAL

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)

Control/Standard-care

ACTIVE COMPARATOR

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

Interventions

Measurement Based Care (MBC) OTHER

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.

Measurement Based Care MBC

Control/Standard-care OTHER

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.

Control/Standard-care

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead
• University of Toronto: collaborator

Study Sites (6)

Bolan Medical Complex

Quetta, Balochistan, Pakistan

Location

Services Hospital

Lahore, Punjab Province, Pakistan

Location

Nishtar Hospital

Multan Khurd, Punjab Province, Pakistan

Location

Benazir Bhutto Hospital

Rawalpindi, Punjab Province, 203393, Pakistan

Location

Civil Hospital

Karachi, Sindh, Pakistan

Location

Civil Hospital

Hyderābād, Pakistan

Location

Related Publications (1)

• Husain MI, Nigah Z, Ansari SUH, Khoso AB, Kiran T, Umer M, Ansari MA, Bhatia MR, Khan SA, Husain MO, Malik AG, Naqvi HA, Qadir A, Rajput AH, Saqib M, Ilyas M, Doutani MUK, Sherzad S, Siddiqui KMS, Tahir Z, Wang W, Husain N, Chaudhry N, Chaudhry IB, Mulsant BH. Measurement-Based Care to Enhance Antidepressant Treatment Outcomes in Major Depressive Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2529427. doi: 10.1001/jamanetworkopen.2025.29427.

  PMID: 40892412 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This will be an assessor blind, randomized controlled trial. Due to the nature of the interventions, it will be impossible to blind clinicians in participating centres or the participants themselves. Before assessments, participants will be asked not to reveal any information about treatment to assessors. To avoid unblinding, outcome assessors will be located separately from treatment providers, and we will assign new outcome assessors in cases of unintentional unblinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 allocation to measurement-based vs. standard-care.

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 24, 2022
• Study Start: September 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: January 30, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (6)