Antidepressant Incomplete Response Depression (DRIA)
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Purpose
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.
| Condition |
|---|
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Major Depressive Disorder |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Assessment of Therapeutic Strategies in Unipolar Depression With Incomplete Response to a Antidepressant Treatment in Regular Clinical Practicing. |
- 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…) [ Time Frame: 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). ] [ Designated as safety issue: No ]
- Clinical assessment [ Time Frame: 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). ] [ Designated as safety issue: No ]
- Visits to nurse, psychiatrics: Hospitalization, social support: Productivity assessment [ Time Frame: 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). ] [ Designated as safety issue: No ]
| Enrollment: | 364 |
| Study Start Date: | October 2008 |
| Study Completion Date: | November 2009 |
| Groups/Cohorts |
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|
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.
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Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| Spain | |
| Research Site | |
| Alcoy, Alicante, Spain | |
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| Benidorm, Alicante, Spain | |
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| Villajoyosa, Alicante, Spain | |
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| Oviedo, Asturias, Spain | |
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| Merida, Badajoz, Spain | |
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| Inca, Baleares, Spain | |
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| Palma de Mallorca, Baleares, Spain | |
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| El Hospitalet de Llobregat, Barcelona, Spain | |
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| Martorell, Barcelona, Spain | |
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| Vic, Barcelona, Spain | |
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| San Fernando, Cadiz, Spain | |
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| Villamartin, Cadiz, Spain | |
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| Santander, Cantabria, Spain | |
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| Murcia, Caravaca, Spain | |
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| Villarreal, Castellon, Spain | |
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| Guadix, Granada, Spain | |
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| Mondragon, Guipuzcoa, Spain | |
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| Las Palmas de Gran Canaria, Las Palmas, Spain | |
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| Lleida, Lerida, Spain | |
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| Alcala de Henares, Madrid, Spain | |
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| Alcobendas, Madrid, Spain | |
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| Colmenar Viejo, Madrid, Spain | |
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| Torrejon de Ardoz, Madrid, Spain | |
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| Cartagena, Murcia, Spain | |
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| Pamplona, Navarra, Spain | |
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| Valls, Tarragona, Spain | |
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| La Cuesta de Arguijon, Tenerife, Spain | |
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| Santa Cruz de Tenerife, Tenerife, Spain | |
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| Talavera de La Reina, Toledo, Spain | |
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| Gandia, Valencia, Spain | |
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| Bilbao, Vizcaya, Spain | |
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| Getxo, Vizcaya, Spain | |
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| Zalla, Vizcaya, Spain | |
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| Benavente, Zamora, Spain | |
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| Albacete, Spain | |
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| Almeria, Spain | |
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| Barcelona, Spain | |
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| Burgos, Spain | |
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| Ceuta, Spain | |
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| Cordoba, Spain | |
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| Madrid, Spain | |
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| Malaga, Spain | |
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| Salamanca, Spain | |
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| Sevilla, Spain | |
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| Tarragona, Spain | |
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| Valencia, Spain | |
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| Valladolid, Spain | |
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| Zaragoza, Spain | |
More Information
No publications provided
| Responsible Party: | Teresa Díez, PhD, Local MC Neuroscience Therapeutic Area Manager, AstraZeneca Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00782964 History of Changes |
| Other Study ID Numbers: | NIS-NES-DUM-2007/4 |
| Study First Received: | October 30, 2008 |
| Last Updated: | December 23, 2009 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by AstraZeneca:
|
Depression Major Depressive Disorder SSRI resistant depression strategies in depression |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders |
Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013