First choIce Antidepressants: General Practitioner's Treatment Approach in the Czech Republic

NCT05291897 | Terminated

• 1 other identifier: 153(B)LM21212
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 6

Brief Summary

According to the local guidelines (Recommendation for General Practitioners), the first choice Anti-Depressant (AD) in Major Depressive Disorder (MDD) in primary care should be selective serotonin reuptake inhibitors (SSRI), e.g. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, in depression with anxiety and insomnia is preferable trazodone and in severer disorders mirtazapine. Despite all these molecules have a very good antidepressant effect, there are differences in side effect scale and tolerability. The aim of this Study is describing of real treatment practice and MDD management in primary care - aimed to evaluate effectiveness of the treatments in depression and related symptoms: insomnia, anxiety, anhedonia and sexual dysfunction. The primary objective of the Study is to describe the diagnostic process and treatment patterns in MDD- treatment of choice (pharmacologic with details of first choice antidepressant) in the office of GP's. The secondary objective is to evaluate efficiency of the treatments in depression and related symptoms: insomnia, anxiety, anhedonia and sexual dysfunction and to monitor the type of side effects and comedication during the 8-weeks treatment.

Conditions

Major Depressive Disorder Co-Occurrent With Anxiety; Adult Patients; Newly Diagnosed Depression

Keywords

depression; first choice antidepressant; insomnia; real world data; MDD; MindG bracelets; anxiety; anhedonia; sexual disfunction

Outcome Measures

Primary Outcomes (5)

• Description of the type of antidepressant

  The variable type of antidepressant will be observed and evaluated.

  patient duration: from enrollment to end of treatment for 8 weeks

• Description of the dose of the antidepressant

  The difference between the therapeutic and prescribed dose of antidepressant will be computed as therapeutic dose - prescribed dose.

  patient duration: from enrollment to end of treatment for 8 weeks

• Description of the increase of dose

  The variable the increase of dose will be computed as changes of dose of comedication drug at the end of follow-up - dose of the drug at the start of follow-up.

  patient duration: from enrollment to end of treatment for 8 weeks

• Description of the time on an antidepressant without change of dose

  Time on an antidepressant without change of dose will be computed as date of increase of dose - date of enrolment visit.

  patient duration: from enrollment to end of treatment for 8 weeks

• Description of the maximum daily dose of antidepressant

  The variable maximum total daily dose will be observed and evaluated.

  patient duration: from enrollment to end of treatment for 8 weeks

Secondary Outcomes (13)

• Treatment efficiency - insomnia - change in total sleep time

  patient duration: from enrollment to end of treatment for 8 weeks

• Treatment efficiency - insomnia - sleep efficiency

  patient duration: from enrollment to end of treatment for 8 weeks

• Treatment efficiency - insomnia - sleep latency

  patient duration: from enrollment to end of treatment for 8 weeks

• Treatment efficiency - insomnia - sleep bouts

  patient duration: from enrollment to end of treatment for 8 weeks

• Treatment efficiency - insomnia - sleep bouts

  patient duration: from enrollment to end of treatment for 8 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with newly diagnosed depression included in the Non-Interventional Study (NIS) must be assigned to the therapy before and independently with respect to the decision of being enrolled in the Study.

You may qualify if:

• Signing of the Inform Consent Form (Personal Data Protection Consent included)
• Adults male and female newly diagnosed with depression in care of the general practitioner

You may not qualify if:

• Patients previously treated with depression or patients treated by a psychiatrist
• Pregnancy and breast-feeding
• Acute myocardial infarction
• Significant risk of suicide
• Concomitant antidepressant medication

Sponsors & Collaborators

• Angelini Pharma Česká republika s.r.o.: lead
• Institut biostatistiky a analýz, s.r.o. (IBA): collaborator
• MINDPAX, s.r.o.: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (6)

MUDr. František Rolinek, s.r.o.

Brno, 602 00, Czechia

Location

Artemisia všeobecné lékařství, s.r.o.

Brno, Czechia

Location

MEDIGATE Care s.r.o.

Hradec Králové, 50009, Czechia

Location

AAAmbulance, s.r.o.

Litoměřice, 14000, Czechia

Location

Poliklinika Prosek

Prague, 190 00, Czechia

Location

PragMed, s.r.o.

Prague, 70200, Czechia

Location

MeSH Terms

Conditions

Depression; Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Anhedonia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Filip Španiel, MD, PhD

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: March 23, 2022
• Study Start: October 15, 2021
• Primary Completion: June 10, 2023
• Study Completion: June 30, 2023
• Last Updated: July 18, 2023

Record last verified: 2022-03

Locations

CZ (6)