Adult Patients Clinical Trial
— FIATOfficial title:
First choIce Antidepressants: General Practitioner's Treatment Approach in the Czech Republic (FIAT)
Verified date | March 2022 |
Source | Angelini Pharma Ceská republika s.r.o. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Terminated |
Enrollment | 28 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Czechia | Artemisia všeobecné lékarství, s.r.o. | Brno | |
Czechia | MUDr. František Rolinek, s.r.o. | Brno | |
Czechia | MEDIGATE Care s.r.o. | Hradec Králové | |
Czechia | AAAmbulance, s.r.o. | Litomerice | |
Czechia | Poliklinika Prosek | Praha | |
Czechia | PragMed, s.r.o. | Praha |
Lead Sponsor | Collaborator |
---|---|
Angelini Pharma Ceská republika s.r.o. | Institut biostatistiky a analýz, s.r.o. (IBA), MINDPAX, s.r.o., National Institute of Mental Health (NIMH) |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. |
patient duration: from enrollment to end of treatment for 8 weeks | |
Secondary | 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). |
patient duration: from enrollment to end of treatment for 8 weeks | |
Secondary | 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. |
patient duration: from enrollment to end of treatment for 8 weeks | |
Secondary | 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. |
patient duration: from enrollment to end of treatment for 8 weeks | |
Secondary | 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. |
patient duration: from enrollment to end of treatment for 8 weeks | |
Secondary | 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. |
patient duration: from enrollment to end of treatment for 8 weeks | |
Secondary | 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. |
patient duration: from enrollment to end of treatment for 8 weeks | |
Secondary | 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. |
patient duration: from enrollment to end of treatment for 8 weeks | |
Secondary | 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. |
patient duration: from enrollment to end of treatment for 8 weeks | |
Secondary | 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. |
patient duration: from enrollment to end of treatment for 8 weeks | |
Secondary | 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. | patient duration: from enrollment to end of treatment for 8 weeks | |
Secondary | 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. | patient duration: from enrollment to end of treatment for 8 weeks | |
Secondary | 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. | patient duration: from enrollment to end of treatment for 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02063763 -
TPO-mimetics Before Splenectomy in Adult Primary Immune Thrombocytopenia Patients.
|
||
Not yet recruiting |
NCT01785654 -
Hemodynamic and Biological Evaluations During Reventilation Collapse in ICU
|
N/A | |
Active, not recruiting |
NCT02232386 -
Phase 2 Study to Assess Activity & Safety of Front-line Ibrutinib + Rituximab in Unfit Chronic Lymphocytic Leukemia
|
Phase 2 | |
Recruiting |
NCT02200159 -
Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU
|
N/A | |
Completed |
NCT01888094 -
SUBclavian Central Venous Catheters Guidance and Examination by UltraSound
|
Phase 2/Phase 3 | |
Completed |
NCT01957020 -
Stereotactic Directional Vacuum-Assisted Breast Biopsy
|
N/A | |
Recruiting |
NCT03282331 -
Lung MORphological Modifications Evaluated by Electrical Impedance Tomography During Preoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation (MORPHEIT Study, an Ancillary Study of PREONIV Trial)
|
N/A | |
Completed |
NCT03203967 -
Epidural Morphine for Postoperative Analgesia After Total Knee Arthroplasty
|
N/A | |
Enrolling by invitation |
NCT05643105 -
Anastomotic Leakage After Colon Cancer Surgery
|
||
Completed |
NCT02202720 -
Evaluation of Richmond Agitation Sedation Scale According to Alveolar Concentration of Sevoflurane During a Sedation With Sevoflurane in ICU Patients
|
Phase 2 | |
Completed |
NCT04206306 -
Functional Recovery Over the First Year After ICU Discharge
|
||
Recruiting |
NCT01782430 -
PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
|
Phase 2/Phase 3 |