Prevalence and Risk Factors in Unipolar Depression Patients Without Remission After One Antidepressant Trial

NCT ID: NCT01887639

Last Updated: 2015-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-09-30

Brief Summary

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A non interventional, descriptive, longitudinal cohort study is designed, trying to obtain local data about the prevalence of non remitted depressed patients after an antidepressant treatment, and to get information about sociodemographic and clinical characteristics of these patients as well as features of their treatments and compare them with those of the patients that achieve remission. Also the effect of patient´s expectation in the treatment outcome will be examined.

Detailed Description

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A non interventional, descriptive, longitudinal cohort study is designed, trying to obtain local data about the prevalence of non remitted depressed patients after an antidepressant treatment, and to get information about sociodemographic and clinical characteristics of these patients as well as features of their treatments and compare them with those of the patients that achieve remission. Also the effect of patient´s expectation in the treatment outcome will be examined.

Non psychotic depressed patients that are initiating an antidepressant treatment will be recruited. Socio demographic and clinical features will be recorded as well as their expectations before the treatment. Severity of depression and treatment characteristics will be recorded after 4 to 8 weeks of drug treatment at an adequate dose. Variables will be compared between the patients that will achieve remission and those that do not.

Conditions

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Non-psychotic Unipolar Major Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Unipolar major depression

Outpatients Individuals between 18 and 75 years old with a current episode of non-psychotic unipolar major depression that are treated with an antidepressant drug according to physician´s current and usual practice.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Female and male aged 18 to 75 years old. Outpatients with a current episode of non-psychotic unipolar major depression according to the DSM IV-TR.

Severity of illness assessed by means of a score ≥ 14 in the HAM D17 Have not been medicated for the current depression episode with an antidepressant Provision of subject informed consent

Exclusion Criteria

Patients participating in any clinical trial, the subject cannot take part in this study.

The individual has participated in the last 3 months (including this study) or is participating in a clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Buenos Aires, , Argentina

Site Status

Research Site

Caba, , Argentina

Site Status

Research Site

Chaco, , Argentina

Site Status

Research Site

Córdoba, , Argentina

Site Status

Research Site

Rosario, , Argentina

Site Status

Research Site

San Miguel de Tucumán, , Argentina

Site Status

Research Site

San Salvador de Jujuy, , Argentina

Site Status

Research Site

Santa Fe, , Argentina

Site Status

Countries

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Argentina

Related Links

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Other Identifiers

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NIS-NAR-XXX-2013/1

Identifier Type: -

Identifier Source: org_study_id

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