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NCT05291897: FIAT
First choIce Antidepressants: General Practitioner's Treatment Approach in the Czech Republic
trial in Major Depressive Disorder Co-Occurrent With Anxiety in 28 participants. Terminated before completion.
10 June 2023
Quick facts
| Lead sponsor | Angelini Pharma Česká republika s.r.o. |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 28 |
| Start date | 15 October 2021 |
| Primary completion | 10 June 2023 |
| Estimated completion | 30 June 2023 |
| Sites | 6 locations across Czechia |
Conditions studied
- Major Depressive Disorder Co-Occurrent With Anxiety — all drugs for Major Depressive Disorder Co-Occurrent With Anxiety →
- Adult Patients — all drugs for Adult Patients →
- Newly Diagnosed Depression — all drugs for Newly Diagnosed Depression →
Sponsor
Angelini Pharma Česká republika s.r.o.
Who can join
18 and older, any sex, with Major Depressive Disorder Co-Occurrent With Anxiety or Adult Patients. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05291897 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Angelini Pharma Česká republika s.r.o.
- Last refreshed: 18 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05291897.
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