Prevalence and Risk Factors in Unipolar… | Clinical Trial

Key information

Conditions

Non-psychotic Unipolar Major Depression

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Buenos Aires, Argentina

About this 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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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 outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: PANTHER

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jun 27, 2013
Registry last updated: Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.