Retrospective Observational Study DIANA Study

Major Depressive Episode Clinical Trial

— DIANA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976793
• Other study ID #: NIS-NRU-ATC-2013/1
• Status: Completed
• Phase: N/A
• First received: October 24, 2013
• Last updated: November 12, 2014
• Start date: December 2013
• Est. completion date: December 2013

Study information

• Verified date: November 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Independent Interdisciplinary Committee of ethical review of clinical trials
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Episode

Locations

Country	Name	City	State
Russian Federation	Research Site	Ivanovo
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhniy Novgorod
Russian Federation	Research Site	Rostov-on-Don
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Stavropol
Russian Federation	Research Site	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 6 months	No
Secondary	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.	up to 6 months	No
Secondary	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	Up to 6 months	No
Secondary	Doses of pharmacological agents used for augmentation	Mean and median doses of pharmacological agents used for augmentation	Up to 6 months	No
Secondary	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	up to 6 months	No

External Links

•   NIS-NRU-ATC-2013/1 Clinical Study Report Synopsis