Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Antidepressant Incomplete Response Depression (DRIA)

23 december 2009 uppdaterad av: AstraZeneca

Assessment of Therapeutic Strategies in Unipolar Depression With Incomplete Response to a Antidepressant Treatment in Regular Clinical Practicing.

Observational, non-interventional, longitudinal, prospective,multicenter, open label (No treatment is involved). 3 assessment will be carried out . The 1st one will be on baseline, the 2sd one after a significant change in pharmacological treatment and 3rd one after a second significant change in pharmacological treatment. If there isn´t any significant change in therapeutic plan a control assessment will be carry out in week 10th and 24th. A significant treatment change is defined as a change in SSRI/SNRI, to add another SSRI/SNRI or a augmentation treatment added to SSRI/SNRI. The primary objective is to describe therapeutical strategies (antidepressant change, association with another antidepressant or association with another treatment) in the management of patients with MDD with incomplete response or intolerance to an antidepressant after a first or a second failure; and when the psychiatrist decide a change of strategy. Secondary objectives include: 1 - To describe the clinic profile of depressive patients with incomplete response or intolerance to an antidepressant after a first or a second failure; 2- To describe the profile of patients based on therapeutic strategies used and number of therapeutic strategies; 4- Evaluate the use of health resource due to lack of fast onset of action, and social cost (productivity, care givers…); 5 - To associate clinical variable with therapeutic action by psychiatrist.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Observationell

Inskrivning (Faktisk)

364

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Spanien
      • Albacete, Spanien
        • Research Site
      • Almeria, Spanien
        • Research Site
      • Barcelona, Spanien
        • Research Site
      • Burgos, Spanien
        • Research Site
      • Ceuta, Spanien
        • Research Site
      • Cordoba, Spanien
        • Research Site
      • Madrid, Spanien
        • Research Site
      • Malaga, Spanien
        • Research Site
      • Salamanca, Spanien
        • Research Site
      • Sevilla, Spanien
        • Research Site
      • Tarragona, Spanien
        • Research Site
      • Valencia, Spanien
        • Research Site
      • Valladolid, Spanien
        • Research Site
      • Zaragoza, Spanien
        • Research Site
    • Alicante
      • Alcoy, Alicante, Spanien
        • Research Site
      • Benidorm, Alicante, Spanien
        • Research Site
      • Villajoyosa, Alicante, Spanien
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spanien
        • Research Site
    • Badajoz
      • Merida, Badajoz, Spanien
        • Research Site
    • Baleares
      • Inca, Baleares, Spanien
        • Research Site
      • Palma de Mallorca, Baleares, Spanien
        • Research Site
    • Barcelona
      • El Hospitalet de Llobregat, Barcelona, Spanien
        • Research Site
      • Martorell, Barcelona, Spanien
        • Research Site
      • Vic, Barcelona, Spanien
        • Research Site
    • Cadiz
      • San Fernando, Cadiz, Spanien
        • Research Site
      • Villamartin, Cadiz, Spanien
        • Research Site
    • Cantabria
      • Santander, Cantabria, Spanien
        • Research Site
    • Caravaca
      • Murcia, Caravaca, Spanien
        • Research Site
    • Castellon
      • Villarreal, Castellon, Spanien
        • Research Site
    • Granada
      • Guadix, Granada, Spanien
        • Research Site
    • Guipuzcoa
      • Mondragon, Guipuzcoa, Spanien
        • Research Site
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spanien
        • Research Site
    • Lerida
      • Lleida, Lerida, Spanien
        • Research Site
    • Madrid
      • Alcala de Henares, Madrid, Spanien
        • Research Site
      • Alcobendas, Madrid, Spanien
        • Research Site
      • Colmenar Viejo, Madrid, Spanien
        • Research Site
      • Torrejon de Ardoz, Madrid, Spanien
        • Research Site
    • Murcia
      • Cartagena, Murcia, Spanien
        • Research Site
    • Navarra
      • Pamplona, Navarra, Spanien
        • Research Site
    • Tarragona
      • Valls, Tarragona, Spanien
        • Research Site
    • Tenerife
      • La Cuesta de Arguijon, Tenerife, Spanien
        • Research Site
      • Santa Cruz de Tenerife, Tenerife, Spanien
        • Research Site
    • Toledo
      • Talavera de La Reina, Toledo, Spanien
        • Research Site
    • Valencia
      • Gandia, Valencia, Spanien
        • Research Site
    • Vizcaya
      • Bilbao, Vizcaya, Spanien
        • Research Site
      • Getxo, Vizcaya, Spanien
        • Research Site
      • Zalla, Vizcaya, Spanien
        • Research Site
    • Zamora
      • Benavente, Zamora, Spanien
        • Research Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Outpatient with major depressive disorder, who has a change in pharmacological therapeutic plan after an incomplete response or intolerance to a treatment with an adecuate dosage of an antidepresant (SSRI/NSRI) (20-40 mg fluoxetine, 75-225 mg venlafaxine or equivalent) for at least 6 weeks.

Beskrivning

Inclusion Criteria:

  • Provision of written inform consent
  • Diagnosed of Major Depressive Disorder based on DSM-IV-TR
  • Outpatient who has a change in pharmacological therapeutic plan after an incomplete response or intolerance to a treatment with an adequate dosage of an antidepressant (SSRI/NSRI) 5
  • Able to understand and to comply with requirements of the study

Exclusion Criteria:

  • Mental retardation
  • To have been recruited in a clinical trial in the last 4 weeks or to have planned the inclusion in a clinical trial during the follow-up of this study
  • MDD secondary to substance abuse or somatic illness
  • Actual depressive episode with <4 weeks or >12 months of length
  • Current treatment with >1 SSRI/SRNI or previous treatment with >1 SSRI/SRNI, augmentation treatment with SSRI/SRNI, intravenous antidepressant treatment, TMS, ECT or MAO

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
1
Outpatient with major depressive disorder, who has a change in pharmacological therapeutical plan after an incomplete response or intolerance to a treatment with an adequate dosage of an antidepressant (SSRI/NSRI) (20-40 mg fluoxetine, 75-225 mg venlafaxine or equivalent) for at least 6 weeks.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Profile of use of 3 group of strategies: 1 - Change to another antidepressive agent (Quetiapine, Lamotrigine, antidepressant…) 2- Association with another antidepressant 3- Association with any other treatment (antipsychotics, lithium…)
Tidsram: Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).
Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).

Sekundära resultatmått

Resultatmått
Tidsram
Clinical assessment
Tidsram: Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).
Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).
Visits to nurse, psychiatrics: Hospitalization, social support: Productivity assessment
Tidsram: Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).
Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2008

Avslutad studie (Faktisk)

1 november 2009

Studieregistreringsdatum

Först inskickad

30 oktober 2008

Först inskickad som uppfyllde QC-kriterierna

30 oktober 2008

Första postat (Uppskatta)

31 oktober 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

24 december 2009

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 december 2009

Senast verifierad

1 december 2009

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NIS-NES-DUM-2007/4

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Major depressiv sjukdom

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Austria

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera