Clinical trial NCT05291897: First choIce Antidepressants: General Practitioner's Treatment Approach in the Czech Republic
Official title: First choIce Antidepressants: General Practitioner's Treatment Approach in the Czech Republic (FIAT)
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
Lead sponsor: Angelini Pharma Česká republika s.r.o.
Sponsor class: INDUSTRY
Collaborators: name: Institut biostatistiky a analýz, s.r.o. (IBA)
name: MINDPAX, s.r.o.
name: National Institute of Mental Health (NIMH)
First posted: 2022-03-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Research question:

What are the common clinical practices adopted by general practitioner - diagnostic process and treatment of choice (pharmacologic with details of first choice antidepressant) in patients with newly diagnosed depression and how the diagnosis is performed.

Data sources:

Validated questionnaires (PHQ-9, GAD-7, SHAPS), quality of sleep measures with wrist actigraphy monitor. Questions dedicated to sexual dysfunctions. Data about patient's history, diagnosis, treatment and relevant side effects collected directly to the database.

Variables:

Primary Variables Sex and age of the patient. Type of treatment - one of the first line antidepressants available in GP's office (SSRIs, trazodone or mirtazapine) and specifications regarding the treatment approach: initiation dose of treatment, therapeutic dose of treatment, date of the dose increase, total day dose of treatment.

Secondary Variables Insomnia, anxiety and anhedonia will be evaluated by differences of scores of questionnaires (before and after treatment). Sexual dysfunction will be evaluated by differences of answers (before and after treatment).

* Proportional change in total sleep time (TST) before (1 day) /after (8 weeks) the initiation of treatment (TST is defined as the amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time).
* Sleep efficiency (time asleep / (total time in bed - time to fall asleep).
* Sleep latency (the duration of time from bedtime, to the onset of sleep).
* Sleep bouts (the number of occurrences of a bout (or multiple bouts), the average length of the bout(s), the total time spent in the bouts, and the total count level of the bouts).
* Sleep fragmentation index (index of restlessness during the sleep period expressed as a percentage).

Monitoring of the type of side effects and comedication during the 8-weeks.

Statistical methods:

Categorical parameters will be described by absolute and relative frequencies. Relative frequencies will be calculated based on the number of patients in relevant subgroup. Continuous parameters will be described by mean and standard deviation (SD) and median with minimum and maximum, together with the total number of non-missing observations.

The differences of the scores of the questionnaires (measured before and after treatment) will be also described by standard characteristics as mean (SD) and median (minimum-maximum). These differences will be tested by paired test (paired t-test or paired Wilcoxon test in dependence on meeting prerequisites). Differences with p-values \< 0.05 will be statistically significant (analysis will be performed with level of significance α=0.05).

All statistical tests and confidence intervals will be of exploratory nature.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Description of the type of antidepressant
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
measure: Description of the dose of the antidepressant
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
measure: Description of the increase of dose
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
measure: Description of the time on an antidepressant without change of dose
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
measure: Description of the maximum daily dose of antidepressant
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
Secondary outcomes:
measure: Treatment efficiency - insomnia - change in total sleep time
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
measure: Treatment efficiency - insomnia - sleep efficiency
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
measure: Treatment efficiency - insomnia - sleep latency
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
measure: Treatment efficiency - insomnia - sleep bouts
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
measure: Treatment efficiency - insomnia - sleep bouts
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
measure: Treatment efficiency - insomnia - sleep bouts
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
measure: Treatment efficiency - insomnia - sleep fragmentation index
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
measure: Treatment efficiency - anxiety
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
measure: Treatment efficiency - anhedonia
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
measure: Treatment efficiency - level of depression
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
measure: Treatment efficiency - sexual dysfunction
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
measure: Treatment efficiency - adverse events
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
measure: Monitoring of the type of comedication during the 8-weeks
timeFrame: patient duration: from enrollment to end of treatment for 8 weeks
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: MUDr. František Rolinek, s.r.o.
city: Brno
country: Czechia
facility: Artemisia všeobecné lékařství, s.r.o.
city: Hradec Králové
country: Czechia
facility: MEDIGATE Care s.r.o.
city: Litoměřice
country: Czechia
facility: AAAmbulance, s.r.o.
city: Praha
country: Czechia
facility: Poliklinika Prosek
city: Praha
country: Czechia
facility: PragMed, s.r.o.
Study officials:
affiliation: National Institute of Mental Health (NIMH)
name: Filip Španiel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: