Retrospective Observational Study DIANA Study

Completed

• Conditions: Major Depressive Episode

• Registration Number: NCT01976793
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-06
• Study Start: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-12
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Doses of pharmacological agents used for augmentation	Up to 6 months	Mean and median doses of pharmacological agents used for augmentation
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

Trial Locations

Locations (1)

Research Site; 🇷🇺 Yaroslavl, Russian Federation