Clinical trial NCT01887639: Prevalence and Risk Factors in Unipolar Depression Patients Without Remission After One Antidepressant Trial
Official title: Prevalence and Risk Factors in Unipolar Depression Patients Without Remission After One Antidepressant Trial: PANTHER Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-psychotic Unipolar Major Depression
Keywords: Non-psychotic unipolar major depression
Resistant depression
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-06-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of patients with unipolar major depression that do not achieve remission after one antidepressant treatment.
timeFrame: 12 weeks
Secondary outcomes:
measure: 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.
timeFrame: 12 weeks
measure: Comparison of the depression severity change assessed by the physician with the evaluation done by the patient
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Research Site
city: Caba
country: Argentina
facility: Research Site
city: Chaco
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: San Salvador de Jujuy
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Tucuman
country: Argentina
facility: Research Site
Study officials:
References: