Retrospective Observational Study DIANA Study

NCT01976793 | Completed

• 1 other identifier: NIS-NRU-ATC-2013/1
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 8

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.

Conditions

Major Depressive Episode

Keywords

Recurrent depressive disorder; Depression; Depressive episode; Atypical antipsychotics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Pharmacotherapy strategy for the second line treatment

  up to 6 months

• International Non-Proprietary Name (INN) of pharmacological agents prescribed for augmentation

  Up to 6 months

• Doses of pharmacological agents used for augmentation

  Up to 6 months

• Source of the patient's referral to a psychiatrist

  up to 6 months

Study Arms (1)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \. 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (8)

Research Site

Ivanovo, Russia

Location

Research Site

Kazan', Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Nizhny Novgorod, Russia

Location

Research Site

Rostov-on-Don, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Stavropol, Russia

Location

Research Site

Yaroslavl, Russia

Location

Related Links

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

MeSH Terms

Conditions

Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Alla Avedisova, Prof

  Center of Social and Forensic Psychiatry, Moscow

  PRINCIPAL INVESTIGATOR

• Karin Otter, PhD

  AstraZeneca Russia

  STUDY DIRECTOR

• Anatoly Smulevich, Prof

  Scientific centef of Mental Health, Moscow

  PRINCIPAL INVESTIGATOR

• Galina Mazo, Prof

  St Petersburg Scientific Psyconeurology institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 6, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

RU (8)