Clinical trial NCT01976793: Retrospective Observational Study DIANA 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Episode
Keywords: Recurrent depressive disorder
Depression
Depressive episode
Atypical antipsychotics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-11-06
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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).

Primary outcomes:
measure: Duration of treatment considered as time between initiation of antidepressant monotherapy and the alteration and/or augmentation of pharmacotherapy
timeFrame: up to 6 months
Secondary outcomes:
measure: Pharmacotherapy strategy for the second line treatment
timeFrame: up to 6 months
measure: International Non-Proprietary Name (INN) of pharmacological agents prescribed for augmentation
timeFrame: Up to 6 months
measure: Doses of pharmacological agents used for augmentation
timeFrame: Up to 6 months
measure: Source of the patient's referral to a psychiatrist
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Ivanovo
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Stavropol
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
Study officials:
affiliation: Center of Social and Forensic Psychiatry, Moscow
name: Alla Avedisova, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Russia
name: Karin Otter, PhD
role: STUDY_DIRECTOR
affiliation: Scientific centef of Mental Health, Moscow
name: Anatoly Smulevich, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: St Petersburg Scientific Psyconeurology institute
name: Galina Mazo, Prof
role: PRINCIPAL_INVESTIGATOR
References: