Retrospective Observational Study 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.

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Key information

Conditions

Major Depressive Episode Behavior Behavioral Symptoms Depression Depressive Disorder Mental Disorders Mood Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Ivanovo, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

Pharmacotherapy strategy for the second line treatment

Time frame: 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

Time frame: 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

Time frame: Up to 6 months

Mean and median doses of pharmacological agents used for augmentation
Source of the patient's referral to a psychiatrist

Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: DIANA

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Nov 6, 2013
Registry last updated: Nov 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed