Clinical trial NCT00782964: Antidepressant Incomplete Response Depression
Official title: Assessment of Therapeutic Strategies in Unipolar Depression With Incomplete Response to a Antidepressant Treatment in Regular Clinical Practicing.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Keywords: Depression
Major Depressive Disorder
SSRI resistant depression
strategies in depression
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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…)
timeFrame: 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).
Secondary outcomes:
measure: Clinical assessment
timeFrame: 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).
measure: Visits to nurse, psychiatrics: Hospitalization, social support: Productivity assessment
timeFrame: 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).
Other outcomes:
Locations:
city: Alcoy
country: Spain
facility: Research Site
state: Alicante
city: Benidorm
country: Spain
facility: Research Site
state: Alicante
city: Villajoyosa
country: Spain
facility: Research Site
state: Alicante
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Merida
country: Spain
facility: Research Site
state: Badajoz
city: Inca
country: Spain
facility: Research Site
state: Baleares
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Baleares
city: El Hospitalet de Llobregat
country: Spain
facility: Research Site
state: Barcelona
city: Martorell
country: Spain
facility: Research Site
state: Barcelona
city: Vic
country: Spain
facility: Research Site
state: Barcelona
city: San Fernando
country: Spain
facility: Research Site
state: Cadiz
city: Villamartin
country: Spain
facility: Research Site
state: Cadiz
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: Murcia
country: Spain
facility: Research Site
state: Caravaca
city: Villarreal
country: Spain
facility: Research Site
state: Castellon
city: Guadix
country: Spain
facility: Research Site
state: Granada
city: Mondragon
country: Spain
facility: Research Site
state: Guipuzcoa
city: Las Palmas de Gran Canaria
country: Spain
facility: Research Site
state: Las Palmas
city: Lleida
country: Spain
facility: Research Site
state: Lerida
city: Alcala de Henares
country: Spain
facility: Research Site
state: Madrid
city: Alcobendas
country: Spain
facility: Research Site
state: Madrid
city: Colmenar Viejo
country: Spain
facility: Research Site
state: Madrid
city: Torrejon de Ardoz
country: Spain
facility: Research Site
state: Madrid
city: Cartagena
country: Spain
facility: Research Site
state: Murcia
city: Pamplona
country: Spain
facility: Research Site
state: Navarra
city: Valls
country: Spain
facility: Research Site
state: Tarragona
city: La Cuesta de Arguijon
country: Spain
facility: Research Site
state: Tenerife
city: Santa Cruz de Tenerife
country: Spain
facility: Research Site
state: Tenerife
city: Talavera de La Reina
country: Spain
facility: Research Site
state: Toledo
city: Gandia
country: Spain
facility: Research Site
state: Valencia
city: Bilbao
country: Spain
facility: Research Site
state: Vizcaya
city: Getxo
country: Spain
facility: Research Site
state: Vizcaya
city: Zalla
country: Spain
facility: Research Site
state: Vizcaya
city: Benavente
country: Spain
facility: Research Site
state: Zamora
city: Albacete
country: Spain
facility: Research Site
city: Almeria
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Burgos
country: Spain
facility: Research Site
city: Ceuta
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Tarragona
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
References: