Non-psychotic Unipolar Major Depression Clinical Trial
— PANTHEROfficial title:
Prevalence and Risk Factors in Unipolar Depression Patients Without Remission After One Antidepressant Trial: PANTHER Study
| Verified date | July 2015 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Argentina: Human Research Bioethics Committee |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | September 2014 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Argentina,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |