This trial is active, not recruiting.

Condition mild to moderate depression.
Treatments antidepressants, active monitoring
Sponsor Fundació Sant Joan de Déu
Start date June 2013
End date July 2014
Trial size 263 participants
Trial identifier NCT02245373, Infap


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Naturalistic assignment: Patients whose physician decides to indicate antidepressants.
Naturalistic assignment: Patients whose physician considers starting an Active Monitoring intervention.
active monitoring

Primary Outcomes

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.

Secondary Outcomes

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.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patients whose GP considers to have major depression. The indication of pharmacological or non-pharmacological treatment will be based strictly on the clinical judgment of the physician. 2. Adults (≥18 years) 3. Informed consent signed by the physician and the patient to participate in the study. Exclusion Criteria: 1. Use of antidepressant drugs during the previous 60 days to inclusion date. 2. Alcohol or other toxic abuse. 3. Psychosis or bipolar disorder identified in the psychiatric interview 4. Use in the last 6 months of antipsychotic drugs, lithium or antiepileptic 5. Health status (pregnancy) and / or disease and / or treatments that contraindicate the use of antidepressant drugs. 6. Terminal illness.

Additional Information

Official title Cost-effectiveness of a Non-Pharmacological Treatment (Active Monitoring) vs. a Pharmacological Treatment for Major Depression in Primary Care. INFAP Study.
Principal investigator Antoni Serrano, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Fundació Sant Joan de Déu.