- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01976793
Retrospective Observational Study DIANA Study (DIANA)
Retrospective Observational Study to Estimate the Duration of Initial Antidepressant Treatment in Patients With Recurrent Depressive Disorder Who Demonstrated a Suboptimal Response to Therapy: DIANA Study
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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-
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Ivanovo, Ryska Federationen
- Research Site
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Kazan, Ryska Federationen
- Research Site
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Moscow, Ryska Federationen
- Research Site
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Nizhniy Novgorod, Ryska Federationen
- Research Site
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Rostov-on-Don, Ryska Federationen
- Research Site
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Saint-Petersburg, Ryska Federationen
- Research Site
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Stavropol, Ryska Federationen
- Research Site
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Yaroslavl, Ryska Federationen
- Research Site
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
1. Female or male aged between 18 and 65 years Inpatients and outpatients diagnosed with an episode of major depression relating to RDD (ICD-10, Version 2010) during the period from January 1, 2012 till September 30, 2013 3. Initially treated with antidepressant monotherapy, using a flexible dosage regimen if required, for at least 2 weeks 4. Initial treatment changed because of a suboptimal response at physician's discretion, which is clearly documented in the patient's medical chart.
Exclusion Criteria:
Patients currently participating in any other clinical or non-interventional trial, or have completed their participation with the last 30 days.
2. Patients with current psychiatric or general medical conditions which require concomitant use of lithium, thyroid hormones, or atypical antipsychotics 3. Patients with unstable general medical condition. 4. Patients who were pregnant or were suspected to be pregnant during the period when a patient had received treatment for MDE (Major Depressive Episode).
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Retrospektiv
Kohorter och interventioner
Grupp / Kohort |
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patients with major depression
Inpatients and outpatients diagnosed with an episode of major depression relating to RDD (ICD-10, Version 2010) during the period from January 1, 2012 till September 30, 2013.
Initially treated with antidepressant monotherapy, using a flexible dosage regimen if required, for at least 2 week
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Duration of treatment considered as time between initiation of antidepressant monotherapy and the alteration and/or augmentation of pharmacotherapy
Tidsram: up to 6 months
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Primary objective: The primary objective of this NIS is to evaluate the duration of treatment with an initial antidepressant taken as monotherapy in patients in whom treatment was changed because of suboptimal response at physician's discretion.
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up to 6 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Pharmacotherapy strategy for the second line treatment
Tidsram: up to 6 months
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Distribution of the various pharmacotherapy strategies following suboptimal response: (switch; augmentation; combination of switch and augmentation and discontinuation of pharmacotherapy) among the patients population.
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up to 6 months
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International Non-Proprietary Name (INN) of pharmacological agents prescribed for augmentation
Tidsram: Up to 6 months
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Rate of the different pharmacological agents prescribed for augmentation; rout of their administration; mean and median duration of courses of treatment
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Up to 6 months
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Doses of pharmacological agents used for augmentation
Tidsram: Up to 6 months
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Mean and median doses of pharmacological agents used for augmentation
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Up to 6 months
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Source of the patient's referral to a psychiatrist
Tidsram: up to 6 months
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Distribution of various sources of the patient's referral to a psychiatrist (psychotherapist; neurologist; internist; physician of other speciality; psychologist; came himself; other; and not known
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up to 6 months
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Alla Avedisova, Prof, Center of Social and Forensic Psychiatry, Moscow
- Studierektor: Karin Otter, PhD, AstraZeneca Russia
- Huvudutredare: Anatoly Smulevich, Prof, Scientific centef of Mental Health, Moscow
- Huvudutredare: Galina Mazo, Prof, St Petersburg Scientific Psyconeurology institute
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NIS-NRU-ATC-2013/1
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