Antidepressant Incomplete Response Depression

Major Depressive Disorder Clinical Trial

— DRIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782964
• Other study ID #: NIS-NES-DUM-2007/4
• Status: Completed
• Phase: N/A
• First received: October 30, 2008
• Last updated: December 23, 2009
• Start date: October 2008
• Est. completion date: November 2009

Study information

• Verified date: December 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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…)		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).	No
Secondary	Clinical assessment		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).	No
Secondary	Visits to nurse, psychiatrics: Hospitalization, social support: Productivity assessment		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).	No