Mild to Moderate Depression. Clinical Trial
Official title:
Cost-effectiveness of a Non-Pharmacological Treatment (Active Monitoring) vs. a Pharmacological Treatment for Major Depression in Primary Care. INFAP Study.
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.
| Status | Active, not recruiting |
| Enrollment | 263 |
| Est. completion date | July 2015 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Fundació Sant Joan de Déu |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Measures: Severity of Depression (PHQ-9), Quality of life (EuroQol) and the use of services (Client Service Receipt Inventory, CSRI). | At base Line, 6 months and 12 months. | Yes |
| Secondary | 1.Quality of life of patients with major depression who initiate treatment in Primary Care. | At base line, 6 months and 12 months. | Yes | |
| Secondary | 2. Cost-utility of an antidepressant vs no treatment in mild Depression in Primary. | At base line, 6 months and 12 months. | Yes |