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

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

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Argentina
  • 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
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with unipolar major depression that do not achieve remission after one antidepressant treatment.	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12 weeks
Comparison of the depression severity change assessed by the physician with the evaluation done by the patient	Comparison of the depression severity change assessed by the physician with the evaluation done by the patient by means of the BDI.	12 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• Synopsis

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: June 25, 2013
• First Submitted That Met QC Criteria: June 25, 2013
• First Posted (Estimate): June 27, 2013

Study Record Updates

• Last Update Posted (Estimate): July 30, 2015
• Last Update Submitted That Met QC Criteria: July 29, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Resistant depression; Non-psychotic unipolar major depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: NIS-NAR-XXX-2013/1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No