Non-psychotic Unipolar Major DepressionPANTHERNCT01887639
Prevalence and Risk Factors in Unipolar Depression Patients Without Remission After One Antidepressant Trial
An observational study of Non-psychotic Unipolar Major Depression, run by AstraZeneca at 8 sites in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-psychotic Unipolar Major Depression
- How many people
- 200 participants
- Where
- 8 sitesArgentina
- Study dates
- Sep 2013to Sep 2014
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Argentina8 sites
Research Site
Buenos Aires
Research Site
Caba
Research Site
Chaco
Research Site
Córdoba
Research Site
Rosario
Research Site
San Miguel de Tucumán
Research Site
San Salvador de Jujuy
Research Site
Santa Fe
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-psychotic Unipolar Major Depression
- Keywords
- Non-psychotic unipolar major depression, Resistant depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-psychotic Unipolar Major DepressionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887639
- Sponsor's protocol ID
- NIS-NAR-XXX-2013/1
- Acronym
- PANTHER
- Status last verified
- Jul 2015
- First submitted
- 25 Jun 2013
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors in Unipolar Depression Patients Without Remission After One Antidepressant Trial: PANTHER Study
- ClinicalTrials.gov ID
- NCT01887639
- Acronym / sponsor ID
- PANTHER / NIS-NAR-XXX-2013/1
- Conditions
- Non-psychotic Unipolar Major Depression
- Keywords
- Non-psychotic unipolar major depression, Resistant depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 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
Comparison of the depression severity change assessed by the physician with the evaluation done by the patient
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- SynopsisLink provided by the sponsor.
Related trials for Non-psychotic Unipolar Major Depression
Active, not recruitingObservational study
Multi-Omic, Clinomic and Digitomic Attributes of Major Depression for Integrative Analytics
Major Depressive Disorder, Unipolar, Non-psychotic Major Depressive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-psychotic Unipolar Major Depression, run by AstraZeneca at 8 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with unipolar major depression that do not achieve remission after one antidepressant treatment. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.