Mild to Moderate Depression.NCT02245373
Cost-effectiveness of a Non-Pharmacological Treatment (Active Monitoring) vs. a Pharmacological Treatment for Major Depression in Primary Care.
An observational study of Mild to Moderate Depression., run by Fundació Sant Joan de Déu.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild to Moderate Depression.
- What is being tested?
- Antidepressants and Active Monitoring
- How many people
- 263 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jul 2015
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care patients who suffer from major depression.
Who may be able to join
- 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.
- Adults (≥18 years)
- Informed consent signed by the physician and the patient to participate in the study.
Who cannot join
- Use of antidepressant drugs during the previous 60 days to inclusion date.
- Alcohol or other toxic abuse.
- Psychosis or bipolar disorder identified in the psychiatric interview
- Use in the last 6 months of antipsychotic drugs, lithium or antiepileptic
- Health status (pregnancy) and / or disease and / or treatments that contraindicate the use of antidepressant drugs.
- Terminal illness.
About this study
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.
Read more
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.
- Being tested
- Antidepressants, Active Monitoring
- Keywords
- Depression, Primary Care, Cost-effectiveness, Pharmacological treatment, Watchful-waiting or Active Monitoring.
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntidepressantsDrug
Active MonitoringOther
| Study group | Role | What they receive |
|---|---|---|
| Antidepressants | Naturalistic assignment: Patients whose physician decides to indicate antidepressants. Receives: Drug: Antidepressants | |
| Active Monitoring | Naturalistic assignment: Patients whose physician considers starting an Active Monitoring intervention. Receives: Other: Active Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At base Line, 6 months and 12 months.
Secondary outcomes (2)
1.Quality of life of patients with major depression who initiate treatment in Primary Care.
Measured: At base line, 6 months and 12 months.
2. Cost-utility of an antidepressant vs no treatment in mild Depression in Primary.
Measured: At base line, 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startJun 2013
- Primary completionJul 2014
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate Depression.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 263 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoni Serrano, PhD, Principal investigator, Fundació Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245373
- Sponsor's protocol ID
- Infap
- Status last verified
- Sep 2014
- First submitted
- 10 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
Publications
Rubio-Valera M, Beneitez I, Penarrubia-Maria MT, Luciano JV, Mendive JM, McCrone P, Knapp M, Sabes-Figuera R, Kocyan K, Garcia-Campayo J, Serrano-Blanco A. Cost-effectiveness of active monitoring versus antidepressants for major depression in primary health care: a 12-month non-randomized controlled trial (INFAP study). BMC Psychiatry. 2015 Mar 31;15:63. doi: 10.1186/s12888-015-0448-3.
PubMed 25885818
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of a Non-Pharmacological Treatment (Active Monitoring) vs. a Pharmacological Treatment for Major Depression in Primary Care. INFAP Study.
- ClinicalTrials.gov ID
- NCT02245373
- Acronym / sponsor ID
- Infap
- Conditions
- Mild to Moderate Depression.
- Keywords
- Depression, Primary Care, Cost-effectiveness, Pharmacological treatment, Watchful-waiting or Active Monitoring.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2015 (estimated)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antidepressants | – | Drug: AntidepressantsNaturalistic assignment: Patients whose physician decides to indicate antidepressants. |
| Active Monitoring | – | Other: Active MonitoringNaturalistic assignment: Patients whose physician considers starting an Active Monitoring intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care patients who suffer from major depression.
Key inclusion criteria (3 listed)
- 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.
- Adults (≥18 years)
- Informed consent signed by the physician and the patient to participate in the study.
Key exclusion criteria (6 listed)
- Use of antidepressant drugs during the previous 60 days to inclusion date.
- Alcohol or other toxic abuse.
- Psychosis or bipolar disorder identified in the psychiatric interview
- Use in the last 6 months of antipsychotic drugs, lithium or antiepileptic
- Health status (pregnancy) and / or disease and / or treatments that contraindicate the use of antidepressant drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antidepressants | Drug | Antidepressants |
| Active Monitoring | Other | Active Monitoring |
Primary outcome
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).
2 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
- Derived from this study: PubMed 25885818Rubio-Valera M, Beneitez I, Penarrubia-Maria MT, Luciano JV, Mendive JM, McCrone P, Knapp M, Sabes-Figuera R, Kocyan K, Garcia-Campayo J, Serrano-Blanco A. Cost-effectiveness of active monitoring versus antidepressants for major depression in primary health care: a 12-month non-randomized controlled trial (INFAP study). BMC Psychiatry. 2015 Mar 31;15:63. doi: 10.1186/s12888-015-0448-3.
Related trials for Mild to Moderate Depression.
RecruitingPhase 2
Cross-over Study on the Influence of Fampridine on Working Memory in Mild to Moderate Depression
Working Memory, Mild to Moderate Depression
Recruiting
GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate Depression
Depression, Depression Disorder
Recruiting
Social Prescribing for a Mindful Lifestyle
Depression and/or Anxiety in the Mild-to-moderate Range, Loneliness
Active, not recruiting
iCBT for Seniors With Depression in Primary Care
Depression Mild, Depression Moderate
Active, not recruiting
A Pilot Study of Synbiotics in Adults With Depressive Symptoms
Depressive Symptoms Mild to Moderate in Severity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoni Serrano, PhD principal investigator
Fundació Sant Joan de Déu
Questions about this trial
What is this clinical trial studying?
An observational study of Mild to Moderate Depression., run by Fundació Sant Joan de Déu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02245373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2014.