Major Depressive DisorderDRIANCT00782964
Antidepressant Incomplete Response Depression
An observational study of Major Depressive Disorder, run by AstraZeneca at 48 sites in Spain.
Trial summary
Observational, non-interventional, longitudinal, prospective,multicenter, open label (No treatment is involved). 3 assessment will be carried out . The 1st one will be on baseline, the 2sd one after a significant change in pharmacological treatment and 3rd one after a second significant change in pharmacological… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 364 participants
- Where
- 48 sitesSpain
- Study dates
- Oct 2008to Nov 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient with major depressive disorder, who has a change in pharmacological therapeutic plan after an incomplete response or intolerance to a treatment with an adecuate dosage of an antidepresant (SSRI/NSRI) (20-40 mg fluoxetine, 75-225 mg venlafaxine or equivalent) for at least 6 weeks.
Who may be able to join
- Provision of written inform consent
- Diagnosed of Major Depressive Disorder based on DSM-IV-TR
- Outpatient who has a change in pharmacological therapeutic plan after an incomplete response or intolerance to a treatment with an adequate dosage of an antidepressant (SSRI/NSRI) 5
- Able to understand and to comply with requirements of the study
Who cannot join
- Mental retardation
- To have been recruited in a clinical trial in the last 4 weeks or to have planned the inclusion in a clinical trial during the follow-up of this study
- MDD secondary to substance abuse or somatic illness
- Actual depressive episode with <4 weeks or >12 months of length
- Current treatment with >1 SSRI/SRNI or previous treatment with >1 SSRI/SRNI, augmentation treatment with SSRI/SRNI, intravenous antidepressant treatment, TMS, ECT or MAO
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
Spain48 sites
Research Site
Albacete, Albacete
Research Site
Alcalá de Henares, Madrid
Research Site
Alcobendas, Madrid
Research Site
Alcoy, Alicante
Research Site
Almería, Almeria
Research Site
Arrasate / Mondragón, Guipuzcoa
Research Site
Barcelona
Research Site
Benavente, Zamora
Research Site
Benidorm, Alicante
Research Site
Bilbao, Vizcaya
Research Site
Burgos, Burgos
Research Site
Cartagena, Murcia
Research Site
Ceuta, Ceuta
Research Site
Colmenar Viejo, Madrid
Research Site
Córdoba, Cordoba
Research Site
El Hospitalet de Llobregat, Barcelona
Research Site
Gandia, Valencia
Research Site
Getxo, Vizcaya
Research Site
Guadix, Granada
Research Site
Inca, Balearic Islands
Research Site
La Cuesta de Arguijon, Tenerife
Research Site
Las Palmas de Gran Canaria, Las Palmas
Research Site
Lleida, Lerida
Research Site
Madrid, Madrid
Research Site
Málaga, Malaga
Research Site
Martorell, Barcelona
Research Site
Mérida, Badajoz
Research Site
Murcia, Caravaca
Research Site
Oviedo, Principality of Asturias
Research Site
Palma de Mallorca, Balearic Islands
Research Site
Pamplona, Navarre
Research Site
Salamanca, Salamanca
Research Site
San Fernando, Cadiz
Research Site
Santa Cruz de Tenerife, Tenerife
Research Site
Santander, Cantabria
Research Site
Seville, Sevilla
Research Site
Talavera de la Reina, Toledo
Research Site
Tarragona, Tarragona
Research Site
Torrejón de Ardoz, Madrid
Research Site
Valencia, Valencia
Research Site
Valladolid, Valladolid
Research Site
Valls, Tarragona
Research Site
Vic, Barcelona
Research Site
Villajoyosa, Alicante
Research Site
Villamartín, Cadiz
Research Site
Villarreal, Castellon
Research Site
Zalla, Vizcaya
Research Site
Zaragoza, Zaragoza
About this study
Official title: Assessment of Therapeutic Strategies in Unipolar Depression With Incomplete Response to a Antidepressant Treatment in Regular Clinical Practicing.
Observational, non-interventional, longitudinal, prospective,multicenter, open label (No treatment is involved). 3 assessment will be carried out . The 1st one will be on baseline, the 2sd one after a significant change in pharmacological treatment and 3rd one after a second significant change in pharmacological treatment. If there isn´t any significant change in therapeutic plan a control assessment will be carry out in week 10th and 24th. A significant treatment change is defined as a change in SSRI/SNRI, to add another SSRI/SNRI or a augmentation treatment added to SSRI/SNRI. The primary objective is to describe therapeutical strategies (antidepressant change, association with another antidepressant or association with another treatment) in the management of patients with MDD with incomplete response or intolerance to an antidepressant after a first or a second failure; and when the psychiatrist decide a change of strategy. Secondary objectives include: 1 - To describe the clinic profile of depressive patients with incomplete response or intolerance to an antidepressant after a first or a second failure; 2- To describe the profile of patients based on therapeutic strategies used and number of therapeutic strategies; 4- Evaluate the use of health resource due to lack of fast onset of action, and social cost (productivity, care givers…); 5 - To associate clinical variable with therapeutic action by psychiatrist.
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Major Depressive Disorder, SSRI resistant depression, strategies in depression
- Medical subject headings
- Depressive Disorder, Major, 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 |
|---|---|---|
| 1 | Outpatient with major depressive disorder, who has a change in pharmacological therapeutical plan after an incomplete response or intolerance to a treatment with an adequate dosage of an antidepressant (SSRI/NSRI) (20-40 mg fluoxetine, 75-225 mg venlafaxine or equivalent) for at least 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of use of 3 group of strategies: 1 - Change to another antidepressive agent (Quetiapine, Lamotrigine, antidepressant…) 2- Association with another antidepressant 3- Association with any other treatment (antipsychotics, lithium…)
Measured: Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).
Secondary outcomes (2)
Clinical assessment
Measured: Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).
Visits to nurse, psychiatrics: Hospitalization, social support: Productivity assessment
Measured: Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startOct 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782964
- Sponsor's protocol ID
- NIS-NES-DUM-2007/4
- Acronym
- DRIA
- Status last verified
- Dec 2009
- First submitted
- 30 Oct 2008
- Last updated
- 24 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Therapeutic Strategies in Unipolar Depression With Incomplete Response to a Antidepressant Treatment in Regular Clinical Practicing.
- ClinicalTrials.gov ID
- NCT00782964
- Acronym / sponsor ID
- DRIA / NIS-NES-DUM-2007/4
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Major Depressive Disorder, SSRI resistant depression, strategies in depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Study completion
- Nov 2009 (actual)
- First posted
- 31 Oct 2008 (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.
Observational, non-interventional, longitudinal, prospective,multicenter, open label (No treatment is involved). 3 assessment will be carried out . The 1st one will be on baseline, the 2sd one after a significant change in pharmacological treatment and 3rd one after a second significant change in pharmacological treatment. If there isn´t any significant change in therapeutic plan a control assessment will be carry out in week 10th and 24th. A significant treatment change is defined as a change in SSRI/SNRI, to add another SSRI/SNRI or a augmentation treatment added to SSRI/SNRI. The primary objective is to describe therapeutical strategies (antidepressant change, association with another antidepressant or association with another treatment) in the management of patients with MDD with incomplete response or intolerance to an antidepressant after a first or a second failure; and when the psychiatrist decide a change of strategy. Secondary objectives include: 1 - To describe the clinic profile of depressive patients with incomplete response or intolerance to an antidepressant after a first or a second failure; 2- To describe the profile of patients based on therapeutic strategies used and number of therapeutic strategies; 4- Evaluate the use of health resource due to lack of fast onset of action, and social cost (productivity, care givers…); 5 - To associate clinical variable with therapeutic action by psychiatrist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Outpatient with major depressive disorder, who has a change in pharmacological therapeutical plan after an incomplete response or intolerance to a treatment with an adequate dosage of an antidepressant (SSRI/NSRI) (20-40 mg fluoxetine, 75-225 mg venlafaxine or equivalent) for at least 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient with major depressive disorder, who has a change in pharmacological therapeutic plan after an incomplete response or intolerance to a treatment with an adecuate dosage of an antidepresant (SSRI/NSRI) (20-40 mg fluoxetine, 75-225 mg venlafaxine or equivalent) for at least 6 weeks.
Key inclusion criteria (4 listed)
- Provision of written inform consent
- Diagnosed of Major Depressive Disorder based on DSM-IV-TR
- Outpatient who has a change in pharmacological therapeutic plan after an incomplete response or intolerance to a treatment with an adequate dosage of an antidepressant (SSRI/NSRI) 5
- Able to understand and to comply with requirements of the study
Key exclusion criteria (5 listed)
- Mental retardation
- To have been recruited in a clinical trial in the last 4 weeks or to have planned the inclusion in a clinical trial during the follow-up of this study
- MDD secondary to substance abuse or somatic illness
- Actual depressive episode with <4 weeks or >12 months of length
- Current treatment with >1 SSRI/SRNI or previous treatment with >1 SSRI/SRNI, augmentation treatment with SSRI/SRNI, intravenous antidepressant treatment, TMS, ECT or MAO
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
Profile of use of 3 group of strategies: 1 - Change to another antidepressive agent (Quetiapine, Lamotrigine, antidepressant…) 2- Association with another antidepressant 3- Association with any other treatment (antipsychotics, lithium…)
Time frame: Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).
2 secondary outcomes
Clinical assessment
Time frame: Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).
Visits to nurse, psychiatrics: Hospitalization, social support: Productivity assessment
Time frame: Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).
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 24 Dec 2009.
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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.
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by AstraZeneca at 48 sites in Spain.
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 4 inclusion and 5 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 24 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Spain. 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?
Profile of use of 3 group of strategies: 1 - Change to another antidepressive agent (Quetiapine, Lamotrigine, antidepressant…) 2- Association with another antidepressant 3- Association with any other treatment (antipsychotics, lithium…) (time frame: Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).). 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 24 Dec 2009.