Major Depressive EpisodeDIANANCT01976793
Retrospective Observational Study DIANA Study
An observational study of Major Depressive Episode, run by AstraZeneca at 8 sites in Russia.
Trial summary
This Non-Interventional Study (NIS) is intended to evaluate the duration of treatment with an initial antidepressant taken as monotherapy in patients in whom treatment was changed because of suboptimal response at physician's discretion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Major Depressive Episode
- How many people
- 450 participants
- Where
- 8 sitesRussia
- Study dates
- Dec 2013to Dec 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inpatients and outpatients diagnosed with an episode of major depression relating to RDD (ICD-10, Version 2010) during the period from January 1, 2012 till September 30, 2013. Initially treated with antidepressant monotherapy, using a flexible dosage regimen if required, for at least 2 weeks
Who may be able to join
- 1. Female or male aged between 18 and 65 years Inpatients and outpatients diagnosed with an episode of major depression relating to RDD (ICD-10, Version 2010) during the period from January 1, 2012 till September 30, 2013 3. Initially treated with antidepressant monotherapy, using a flexible dosage regimen if required, for at least 2 weeks 4. Initial treatment changed because of a suboptimal response at physician's discretion, which is clearly documented in the patient's medical chart.
Who cannot join
- Patients currently participating in any other clinical or non-interventional trial, or have completed their participation with the last 30 days.
- 2. Patients with current psychiatric or general medical conditions which require concomitant use of lithium, thyroid hormones, or atypical antipsychotics 3. Patients with unstable general medical condition. 4. Patients who were pregnant or were suspected to be pregnant during the period when a patient had received treatment for MDE (Major Depressive Episode).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Russia8 sites
Research Site
Ivanovo
Research Site
Kazan'
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Rostov-on-Don
Research Site
Saint Petersburg
Research Site
Stavropol
Research Site
Yaroslavl
About this study
Official title: Retrospective Observational Study to Estimate the Duration of Initial Antidepressant Treatment in Patients With Recurrent Depressive Disorder Who Demonstrated a Suboptimal Response to Therapy: DIANA Study
This Non-Interventional Study (NIS) is intended to evaluate the duration of treatment with an initial antidepressant taken as monotherapy in patients in whom treatment was changed because of suboptimal response at physician's discretion. This will address unmet medical needs of patients with a depressive episode related to RDD (ICD-10, Version 2010), who have failed to respond adequately to initial treatment with an antidepressant and contribute to an understanding of the usual approaches that physicians adopt to monitor initial treatment efficacy in RDD (Recurrent Depressive Disorder). The study will also focus on second-line therapy in hard to treat patients, describing the different pharmacotherapeutic strategies.
- Conditions
- Major Depressive Episode
- Keywords
- Recurrent depressive disorder, Depression, Depressive episode, Atypical antipsychotics
- Medical subject headings
- Depressive Disorder, 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 |
|---|---|---|
| patients with major depression | Inpatients and outpatients diagnosed with an episode of major depression relating to RDD (ICD-10, Version 2010) during the period from January 1, 2012 till September 30, 2013. Initially treated with antidepressant monotherapy, using a flexible dosage regimen if required, for at least 2 week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of treatment considered as time between initiation of antidepressant monotherapy and the alteration and/or augmentation of pharmacotherapy
Primary objective: The primary objective of this NIS is to evaluate the duration of treatment with an initial antidepressant taken as monotherapy in patients in whom treatment was changed because of suboptimal response at physician's discretion.
Measured: up to 6 months
Secondary outcomes (4)
Pharmacotherapy strategy for the second line treatment
Distribution of the various pharmacotherapy strategies following suboptimal response: (switch; augmentation; combination of switch and augmentation and discontinuation of pharmacotherapy) among the patients population.
Measured: up to 6 months
International Non-Proprietary Name (INN) of pharmacological agents prescribed for augmentation
Rate of the different pharmacological agents prescribed for augmentation; rout of their administration; mean and median duration of courses of treatment
Measured: Up to 6 months
Doses of pharmacological agents used for augmentation
Mean and median doses of pharmacological agents used for augmentation
Measured: Up to 6 months
Source of the patient's referral to a psychiatrist
Distribution of various sources of the patient's referral to a psychiatrist (psychotherapist; neurologist; internist; physician of other speciality; psychologist; came himself; other; and not known
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive EpisodeStudies 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
- Retrospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alla Avedisova, Prof, Principal investigator, Center of Social and Forensic Psychiatry, MoscowKarin Otter, PhD, Study director, AstraZeneca RussiaAnatoly Smulevich, Prof, Principal investigator, Scientific centef of Mental Health, MoscowGalina Mazo, Prof, Principal investigator, St Petersburg Scientific Psyconeurology institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976793
- Sponsor's protocol ID
- NIS-NRU-ATC-2013/1
- Acronym
- DIANA
- Status last verified
- Nov 2014
- First submitted
- 24 Oct 2013
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study to Estimate the Duration of Initial Antidepressant Treatment in Patients With Recurrent Depressive Disorder Who Demonstrated a Suboptimal Response to Therapy: DIANA Study
- ClinicalTrials.gov ID
- NCT01976793
- Acronym / sponsor ID
- DIANA / NIS-NRU-ATC-2013/1
- Conditions
- Major Depressive Episode
- Keywords
- Recurrent depressive disorder, Depression, Depressive episode, Atypical antipsychotics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Nov 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.
This Non-Interventional Study (NIS) is intended to evaluate the duration of treatment with an initial antidepressant taken as monotherapy in patients in whom treatment was changed because of suboptimal response at physician's discretion. This will address unmet medical needs of patients with a depressive episode related to RDD (ICD-10, Version 2010), who have failed to respond adequately to initial treatment with an antidepressant and contribute to an understanding of the usual approaches that physicians adopt to monitor initial treatment efficacy in RDD (Recurrent Depressive Disorder). The study will also focus on second-line therapy in hard to treat patients, describing the different pharmacotherapeutic strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with major depression | – | –Inpatients and outpatients diagnosed with an episode of major depression relating to RDD (ICD-10, Version 2010) during the period from January 1, 2012 till September 30, 2013. Initially treated with antidepressant monotherapy, using a flexible dosage regimen if required, for at least 2 week |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inpatients and outpatients diagnosed with an episode of major depression relating to RDD (ICD-10, Version 2010) during the period from January 1, 2012 till September 30, 2013. Initially treated with antidepressant monotherapy, using a flexible dosage regimen if required, for at least 2 weeks
Key inclusion criteria (1 listed)
- 1. Female or male aged between 18 and 65 years Inpatients and outpatients diagnosed with an episode of major depression relating to RDD (ICD-10, Version 2010) during the period from January 1, 2012 till September 30, 2013 3. Initially treated with antidepressant monotherapy, using a flexible dosage regimen if required, for at least 2 weeks 4. Initial treatment changed because of a suboptimal response at physician's discretion, which is clearly documented in the patient's medical chart.
Key exclusion criteria (2 listed)
- Patients currently participating in any other clinical or non-interventional trial, or have completed their participation with the last 30 days.
- 2. Patients with current psychiatric or general medical conditions which require concomitant use of lithium, thyroid hormones, or atypical antipsychotics 3. Patients with unstable general medical condition. 4. Patients who were pregnant or were suspected to be pregnant during the period when a patient had received treatment for MDE (Major Depressive Episode).
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
Duration of treatment considered as time between initiation of antidepressant monotherapy and the alteration and/or augmentation of pharmacotherapy
Time frame: up to 6 months
Primary objective: The primary objective of this NIS is to evaluate the duration of treatment with an initial antidepressant taken as monotherapy in patients in whom treatment was changed because of suboptimal response at physician's discretion.
4 secondary outcomes
Pharmacotherapy strategy for the second line treatment
Time frame: up to 6 months
International Non-Proprietary Name (INN) of pharmacological agents prescribed for augmentation
Time frame: Up to 6 months
Doses of pharmacological agents used for augmentation
Time frame: Up to 6 months
Source of the patient's referral to a psychiatrist
Time frame: up to 6 months
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 13 Nov 2014.
- NIS-NRU-ATC-2013/1 Clinical Study Report SynopsisLink provided by the sponsor.
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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.
Alla Avedisova, Prof principal investigator
Center of Social and Forensic Psychiatry, Moscow
Karin Otter, PhD study director
AstraZeneca Russia
Anatoly Smulevich, Prof principal investigator
Scientific centef of Mental Health, Moscow
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 Major Depressive Episode, run by AstraZeneca at 8 sites in Russia.
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 1 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 13 Nov 2014. 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 Russia. 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?
Duration of treatment considered as time between initiation of antidepressant monotherapy and the alteration and/or augmentation of pharmacotherapy (time frame: up to 6 months). 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 13 Nov 2014.