Major Depressive Disorder Co-Occurrent With AnxietyFIATNCT05291897
First choIce Antidepressants: General Practitioner's Treatment Approach in the Czech Republic
An observational study of Major Depressive Disorder Co-Occurrent With Anxiety and Adult Patients, run by Angelini Pharma Česká republika s.r.o. at 6 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder Co-Occurrent With Anxiety, Adult Patients, Newly Diagnosed Depression
- How many people
- 28 participants
- Where
- 6 sitesCzechia
- Study dates
- 15 Oct 2021to 30 Jun 2023
- How long will I take part?
- 8 Weeks
- 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: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Czechia6 sites
MUDr. František Rolinek, s.r.o.
Brno, 602 00
Artemisia všeobecné lékařství, s.r.o.
Brno
MEDIGATE Care s.r.o.
Hradec Králové, 50009
AAAmbulance, s.r.o.
Litoměřice, 14000
Poliklinika Prosek
Prague, 190 00
PragMed, s.r.o.
Prague, 70200
About this study
Official title: First choIce Antidepressants: General Practitioner's Treatment Approach in the Czech Republic (FIAT)
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.
Read more
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.
Read the 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.
- 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
- Medical subject headings
- Depression, Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Anhedonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the type of antidepressant
The variable type of antidepressant will be observed and evaluated.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: patient duration: from enrollment to end of treatment for 8 weeks
Secondary outcomes (13)
Treatment efficiency - insomnia - change in total sleep time
Data about insomnia will be collected via a wireless-enabled wrist-worn actigraphy device.
Variable proportional change in total sleep time is defined as the amount of actual sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time.
Measured: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - insomnia - sleep efficiency
Data about insomnia will be collected via a wireless-enabled wrist-worn actigraphy device.
Variable sleep efficiency is defined as time asleep / (total time in bed - time to fall asleep).
Measured: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - insomnia - sleep latency
Data about insomnia will be collected via a wireless-enabled wrist-worn actigraphy device.
Variable sleep latency is defined as the duration of time from bedtime, to the onset of sleep.
Measured: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - insomnia - sleep bouts
Data about insomnia will be collected via a wireless-enabled wrist-worn actigraphy device.
Variable sleep bouts is defined as the number of occurrences of a bout (or multiple bouts), the average length of the bout(s) will be evaluated and described.
Measured: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - insomnia - sleep bouts
Data about insomnia will be collected via a wireless-enabled wrist-worn actigraphy device.
Variable sleep bouts is defined as the number of occurrences of a bout (or multiple bouts), the total time spent in the bouts will be evaluated and described.
Measured: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - insomnia - sleep bouts
Data about insomnia will be collected via a wireless-enabled wrist-worn actigraphy device.
Variable sleep bouts is defined as the number of occurrences of a bout (or multiple bouts), the total count level of the bouts will be evaluated and described.
Measured: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - insomnia - sleep fragmentation index
Data about insomnia will be collected via a wireless-enabled wrist-worn actigraphy device.
Variable sleep fragmentation index is defined as the index of restlessness during the sleep period expressed as a percentage.
Measured: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - anxiety
Data about anxiety will be collected via the validated self-administered questionnaire - Generalized Anxiety Disorder Questionnaire (GAD-7). Differences in the score of the questionnaire (measured before and after treatment) will be computed as the score of the questionnaire after treatment - the score of the questionnaire before treatment.
Scale values:
GAD-7 - total scores ranged from 0 to 21. A higher total GAD-7 score indicated higher levels of the present state of anxiety.
Measured: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - anhedonia
Data about anhedonia will be collected via the validated self-administered questionnaire - Snaith-Hamilton Pleasure Scale (SHAPS). Differences in the score of the questionnaires (measured before and after treatment) will be computed as the score of the questionnaire after treatment - the score of the questionnaire before treatment.
Scale values:
SHAPS - total scores ranged from 0 to 14. A higher total SHAPS score indicated higher levels of the present state of anhedonia.
Measured: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - level of depression
Data will be collected via the validated self-administered questionnaire-Patient Health Questionnaire-9 (PHQ-9) - Patient Health Questionnaire. Differences in the score of the questionnaire (measured before and after treatment) will be computed as the score of the questionnaire after treatment - the score of the questionnaire before treatment.
Scale values:
PHQ-9 - total scores ranged from 0 to 27. A higher total PHQ-9 score indicated higher levels of the present state of depression.
Measured: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - sexual dysfunction
Sexual dysfunction data will be collected via dedicated questions. Answers to questions about sexual dysfunction at the start and end of treatment will be compared and evaluated.
Measured: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - adverse events
Monitoring of the type of side effects during the 8-weeks. The summary of Adverse events (AE) / Severe Adverse Events (SAE) will present the number and percentage of patients who had at least one AE. The data on AEs/SAEs will be listed.
Measured: patient duration: from enrollment to end of treatment for 8 weeks
Monitoring of the type of comedication during the 8-weeks
Monitoring of the comedication during the 8-weeks. Changes in comedications between the initial and terminal visits will be evaluated and described.
Measured: patient duration: from enrollment to end of treatment for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start15 Oct 2021
- Primary completion10 Jun 2023
- Study completion30 Jun 2023
Why it stopped: The number of needed patients wasn't enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder Co-Occurrent With AnxietyStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Angelini Pharma Česká republika s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut biostatistiky a analýz, s.r.o. (IBA), MINDPAX, s.r.o., National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Filip Španiel, MD, PhD, Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291897
- Sponsor's protocol ID
- 153(B)LM21212
- Acronym
- FIAT
- Status last verified
- Mar 2022
- First submitted
- 12 Jan 2022
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First choIce Antidepressants: General Practitioner's Treatment Approach in the Czech Republic (FIAT)
- ClinicalTrials.gov ID
- NCT05291897
- Acronym / sponsor ID
- FIAT / 153(B)LM21212
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The number of needed patients wasn't enrolled
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Angelini Pharma Česká republika s.r.o.Industry (pharma, biotech, devices)
- Collaborators
- Institut biostatistiky a analýz, s.r.o. (IBA), MINDPAX, s.r.o., National Institute of Mental Health (NIMH)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 23 Mar 2022 (actual)
- 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the type of antidepressant
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
The variable type of antidepressant will be observed and evaluated.
Description of the dose of the antidepressant
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
The difference between the therapeutic and prescribed dose of antidepressant will be computed as therapeutic dose - prescribed dose.
Description of the increase of dose
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
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.
Description of the time on an antidepressant without change of dose
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
Time on an antidepressant without change of dose will be computed as date of increase of dose - date of enrolment visit.
Description of the maximum daily dose of antidepressant
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
The variable maximum total daily dose will be observed and evaluated.
13 secondary outcomes
Treatment efficiency - insomnia - change in total sleep time
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - insomnia - sleep efficiency
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - insomnia - sleep latency
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - insomnia - sleep bouts
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - insomnia - sleep bouts
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - insomnia - sleep bouts
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - insomnia - sleep fragmentation index
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - anxiety
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - anhedonia
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - level of depression
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - sexual dysfunction
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
Treatment efficiency - adverse events
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
Monitoring of the type of comedication during the 8-weeks
Time frame: patient duration: from enrollment to end of treatment for 8 weeks
Results and safety
The study was stopped early (reason given: The number of needed patients wasn't enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
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.
Filip Španiel, MD, PhD principal investigator
National Institute of Mental Health (NIMH)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder Co-Occurrent With Anxiety and Adult Patients, run by Angelini Pharma Česká republika s.r.o. at 6 sites in Czechia.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: The number of needed patients wasn't enrolled). 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?
Description of the type of antidepressant (time frame: patient duration: from enrollment to end of treatment for 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2023.