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

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ClinicalTrials.gov Identifier: NCT01887639
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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.

Condition or disease
Non-psychotic Unipolar Major Depression

Detailed Description:

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Weeks
Official Title: Prevalence and Risk Factors in Unipolar Depression Patients Without Remission After One Antidepressant Trial: PANTHER Study
Study Start Date : September 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Group/Cohort
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.



Primary Outcome Measures :
  1. Percentage of patients with unipolar major depression that do not achieve remission after one antidepressant treatment. [ Time Frame: 12 weeks ]
    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 drug treatment at an adequate dose. Variables will be compared between the patients that will achieve remission and those that do not.


Secondary Outcome Measures :
  1. Clinical, therapeutic and socio-demographic characteristics of resistant depression patients and comparisson of them with the characteristics of the sample of depressed patients in remission. [ Time Frame: 12 weeks ]
    Description of the clinical (Clinical history, episode features, BDI and HAM D17 scores), therapeutic (Type of drug, dose used, treatment period, adherence, presence and type of psychosocial therapy) and socio-demographic (age, gender, civil status, employment status, cohabitation, health insurance) characteristics of resistant depression patients and to compare them with the characteristics of the sample of depressed patients in remission.

  2. Comparison of the depression severity change assessed by the physician with the evaluation done by the patient [ Time Frame: 12 weeks ]
    Comparison of the depression severity change assessed by the physician with the evaluation done by the patient by means of the BDI.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals between 18 and 75 years old that have non-psychotic unipolar major depression and have not been treated for the current episode.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887639


Locations
Argentina
Research Site
Buenos Aires, Argentina
Research Site
Caba, Argentina
Research Site
Chaco, Argentina
Research Site
Cordoba, Argentina
Research Site
Rosario, Argentina
Research Site
San Salvador de Jujuy, Argentina
Research Site
Santa Fe, Argentina
Research Site
Tucuman, Argentina
Sponsors and Collaborators
AstraZeneca

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01887639     History of Changes
Other Study ID Numbers: NIS-NAR-XXX-2013/1
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015

Keywords provided by AstraZeneca:
Non-psychotic unipolar major depression
Resistant depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs