Deprescription of Antidepressants in Primary Care (DAPriCare)

NCT06796946 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 2024-TFG-DEPRES
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction The consumption of antidepressants has increased considerably worldwide, including in Spain. Despite their effectiveness in cases of moderate to severe depression, their long-term use in mild cases is questioned. This study aims to evaluate the effectiveness of a deprescribing intervention in primary care, to reduce the unnecessary consumption of these drugs and improve patients' quality of life. Material and Methods A community-based clinical trial will be carried out before and after in an adult population of residents of an urban area of Cadiz (Spain) who have been prescribed antidepressants in the last year. Participants will be randomly selected and followed up for a predetermined period after consensus. The intervention will consist of a comprehensive evaluation of antidepressant treatment by a team of health professionals. Factors such as indication, dose, and response to treatment will be evaluated, and the Hamilton scale for anxiety and the Beck Inventory for depression will be used. In those cases where it is considered appropriate, a gradual reduction or suspension of the drug will be proposed, always under medical supervision. Conclusions This research will contribute to generating scientific evidence on the safety and efficacy of deprescribing in primary care, promoting a more rational use of antidepressants, and improving the quality of life of patients. The results obtained could have important implications for clinical practice and for the development of clinical practice guidelines.

Conditions

Deprescription; Antidepressants

Keywords

Deprescribing; antidepressants; primary care; clinical trials; mental health; adverse effects

Outcome Measures

Primary Outcomes (2)

• Anxiety

  Hamilton Anxiety Rating Scale (HAM-A) The HAM-A consists of 14 items, each aimed at assessing a different aspect of anxiety as experienced by the individual. These items are rated on a scale, with the total score providing an overall measure of the person's anxiety level. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

  From enrollment to the end of treatment at 8 weeks

• Depression

  Beck Depression Inventory (BDI) 21 items 4 options (0-3) Scores 1-10\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_These ups and downs are considered normal 11-16\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Mild mood disturbance 17-20\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Borderline clinical depression 21-30\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Moderate depression 31-40\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Severe depression over 40\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Extreme depression

  From enrollment to the end of treatment at 8 weeks

Study Arms (3)

Deprescription Partial

EXPERIMENTAL

Deprescription

Drug: Deprescription of Antidepressants (fluoxetine, citalopram, sertraline, paroxetine, and escitalopram)

No Deprescription

NO INTERVENTION

No Deprescription

Deprescription Total

EXPERIMENTAL

Drug: Deprescription of Antidepressants (fluoxetine, citalopram, sertraline, paroxetine, and escitalopram)

Interventions

Deprescription of Antidepressants (fluoxetine, citalopram, sertraline, paroxetine, and escitalopram) DRUG

Deprescription of Antidepressants Reduction or elimination of the dose of antidepressants (fluoxetine, citalopram, sertraline, paroxetine, and escitalopram) taken by patients

Deprescription Partial; Deprescription Total

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be of legal age (≥18 years),
• have received at least one antidepressant prescription in the year before the start of the study,
• and have the physical capacity to go to the health center and the mental capacity to give informed consent

You may not qualify if:

• minors,
• have changed health centers,
• have physical or mental disabilities (including advanced dementia, severe cognitive deficit, advanced Alzheimer's disease, and disability \>70%), or,
• are hospitalized at the time of selection

Sponsors & Collaborators

• University of Huelva: lead

Study Sites (1)

Antonio José Madueño-Caro

Cadiz, 11006, Spain

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Fluoxetine; Citalopram; Sertraline; Paroxetine; Escitalopram

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Juan Gómez-Salgado, professor

CONTACT

+34 959219700; salgado@uhu.es

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Juan Gómez-Salgado

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 28, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ES (1)