Cost-effectiveness of a Non-Pharmacological Treatment (Active Monitoring) vs. a Pharmacological Treatment for Major Depression in Primary Care.
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|ClinicalTrials.gov Identifier: NCT02245373|
Recruitment Status : Unknown
Verified September 2014 by Fundació Sant Joan de Déu.
Recruitment status was: Active, not recruiting
First Posted : September 19, 2014
Last Update Posted : September 19, 2014
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.
|Condition or disease||Intervention/treatment|
|Mild to Moderate Depression.||Drug: Antidepressants Other: Active Monitoring|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||263 participants|
|Observational Model:||Case Control|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Cost-effectiveness of a Non-Pharmacological Treatment (Active Monitoring) vs. a Pharmacological Treatment for Major Depression in Primary Care. INFAP Study.|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||July 2015|
Naturalistic assignment: Patients whose physician decides to indicate antidepressants.
Naturalistic assignment: Patients whose physician considers starting an Active Monitoring intervention.
Other: Active Monitoring
- Compare the cost-effectiveness of active monitoring (standard treatment without antidepressants) vs antidepressants in mild major depression taking into account the severity and disability in Primary Care. The changes at Time Frame will be assessed. [ Time Frame: At base Line, 6 months and 12 months. ]Measures: Severity of Depression (PHQ-9), Quality of life (EuroQol) and the use of services (Client Service Receipt Inventory, CSRI).
- 1.Quality of life of patients with major depression who initiate treatment in Primary Care. [ Time Frame: At base line, 6 months and 12 months. ]
- 2. Cost-utility of an antidepressant vs no treatment in mild Depression in Primary. [ Time Frame: At base line, 6 months and 12 months. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245373
|Principal Investigator:||Antoni Serrano, PhD||Fundació Sant Joan de Déu|