Antidepressant Incomplete Response Depression - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00782964

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
Major Depressive Disorder

MedlinePlus related topics: Antidepressants Depression

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Assessment of Therapeutic Strategies in Unipolar Depression With Incomplete Response to a Antidepressant Treatment in Regular Clinical Practicing.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	300
Study Start Date:	October 2008
Estimated Study Completion Date:	July 2009

Groups/Cohorts
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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782964

Show 48 Study Locations

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Teresa Díez, PhD, Local MC Neuroscience Therapeutic Area Manager )
Study ID Numbers:	NIS-NES-DUM-2007/4
Study First Received:	October 30, 2008
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00782964 History of Changes
Health Authority:	Spain: Ethics Committee

Keywords provided by AstraZeneca:

Depression
Major Depressive Disorder
SSRI resistant depression
strategies in depression

Study placed in the following topic categories:

Depression
Mental Disorders
Psychotropic Drugs
Mood Disorders
Depressive Disorder, Major

Depressive Disorder
Serotonin Uptake Inhibitors
Antidepressive Agents
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Mental Disorders
Therapeutic Uses
Psychotropic Drugs
Mood Disorders
Depressive Disorder, Major

Depressive Disorder
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 07, 2009