Retrospective Observational Study DIANA Study

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01976793

Collaborator

(none)

450

Enrollment

Locations

56.3

Patients Per Site

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Episode

Study Design

Study Type:

Observational

Actual Enrollment :

450 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Duration of treatment considered as time between initiation of antidepressant monotherapy and the alteration and/or augmentation of pharmacotherapy [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.

Secondary Outcome Measures

Pharmacotherapy strategy for the second line treatment [up to 6 months]
Distribution of the various pharmacotherapy strategies following suboptimal response: (switch; augmentation; combination of switch and augmentation and discontinuation of pharmacotherapy) among the patients population.
International Non-Proprietary Name (INN) of pharmacological agents prescribed for augmentation [Up to 6 months]
Rate of the different pharmacological agents prescribed for augmentation; rout of their administration; mean and median duration of courses of treatment
Doses of pharmacological agents used for augmentation [Up to 6 months]
Mean and median doses of pharmacological agents used for augmentation
Source of the patient's referral to a psychiatrist [up to 6 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

Patients currently participating in any other clinical or non-interventional trial, or have completed their participation with the last 30 days.

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).

Contacts and Locations

Locations

	Site	City	Country
1	Research Site	Ivanovo	Russian Federation
2	Research Site	Kazan	Russian Federation
3	Research Site	Moscow	Russian Federation
4	Research Site	Nizhniy Novgorod	Russian Federation
5	Research Site	Rostov-on-Don	Russian Federation
6	Research Site	Saint-Petersburg	Russian Federation
7	Research Site	Stavropol	Russian Federation
8	Research Site	Yaroslavl	Russian Federation

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Alla Avedisova, Prof, Center of Social and Forensic Psychiatry, Moscow
Study Director: Karin Otter, PhD, AstraZeneca Russia
Principal Investigator: Anatoly Smulevich, Prof, Scientific centef of Mental Health, Moscow
Principal Investigator: Galina Mazo, Prof, St Petersburg Scientific Psyconeurology institute