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Cost-effectiveness of a Non-Pharmacological Treatment (Active Monitoring) vs. a Pharmacological Treatment for Major Depression in Primary Care.

NCT02245373 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 263

Last updated 2014-09-19

No results posted yet for this study

Summary

Major Depression (MD) is highly prevalent and has associated a high burden and economic costs. Mild levels of MD could be treated without antidepressants at Primary Care (PC).

Main objectives: 1) To calculate the cost-effectiveness of active monitoring (recommended by NICE) vs pharmacological antidepressant treatment to treat mild MD at PC level.

Methods: 300 patients (≥18 years) with MD (diagnosed by the GP) will be recruited at the PC center. Depending on the level of symptoms, the GP will choose between: A) Active Monitoring (n=150) and B) pharmacological treatment (n=150).

Patients will be followed-up for one year and data will be collected at baseline, 6 and 12 months. Severity will be assessed by Patient Health Questionnaire (PHQ-9), quality of life with the EuroQoL-5D (5 health dimensions), and the use of services with an adapted version of the Client Service Receipt Inventory (including lost productivity).

Cost-effectiveness and cost-utility analysis will be calculated and 5000 bootstrapping replications will be conducted to asses uncertainty. Cost-acceptability curves will be done using two perspectives: the National Health Service perspective and the Societal perspective.

The Propensity Score technique will minimize the absence of randomization, matching cases from both treatment options.

Conditions

  • Mild to Moderate Depression.

Interventions

DRUG

Antidepressants

OTHER

Active Monitoring

Sponsors & Collaborators

  • Fundació Sant Joan de Déu

    lead OTHER

Principal Investigators

  • Antoni Serrano, PhD · Fundació Sant Joan de Déu

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-07-31
Completion
2015-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02245373 on ClinicalTrials.gov