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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
Sponsor:
Information provided by (Responsible Party):
Fundació Sant Joan de Déu

Brief 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.


Condition or disease Intervention/treatment
Mild to Moderate Depression. Drug: Antidepressants Other: Active Monitoring

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Study Type : Observational [Patient Registry]
Actual Enrollment : 263 participants
Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Group/Cohort Intervention/treatment
Antidepressants
Naturalistic assignment: Patients whose physician decides to indicate antidepressants.
Drug: Antidepressants
Active Monitoring
Naturalistic assignment: Patients whose physician considers starting an Active Monitoring intervention.
Other: Active Monitoring



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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. 2. Cost-utility of an antidepressant vs no treatment in mild Depression in Primary. [ Time Frame: At base line, 6 months and 12 months. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care patients who suffer from major depression.
Criteria

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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Fundació Sant Joan de Déu
Investigators
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Principal Investigator: Antoni Serrano, PhD Fundació Sant Joan de Déu

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier: NCT02245373     History of Changes
Other Study ID Numbers: Infap
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014
Keywords provided by Fundació Sant Joan de Déu:
Depression
Primary Care
Cost-effectiveness
Pharmacological treatment
Watchful-waiting or Active Monitoring.
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs