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NCT Number: NCT01344733

A Non Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient With Major Depressive Disorder (MDD)

The study will only detect hypomanic symptoms in treatment resistant MDD patients by mean of HCL-32 administration. Further re-evaluation of MDD diagnosis is not a direct aim of the study. No efficacy and tolerability of pharmacological treatments will be assessed. Patients matching inclusion and exclusion criteria will be enrolled consecutively; each investigator will include the first 10 to 40 patients that will be visited as treatment resistant MDD.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major MDD Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Agrigento, AG, Italy

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent form
  • Male and Female age: 18-65 years
  • Diagnosis of MDD according to DSM-IV TR (296.3 x Major Depressive Disorder, recurrent)
  • Treatment resistance defined as non-response to at least 2 antidepressants given in an ade

Exclusion criteria

  • Patients already participating in clinical trial or any other interventional study
  • Patients unable to understand HCL-32 item meaning

Treatment and study plan

Primary outcomes

  1. To define the potential bipolarity status in treatment resistant MDD patient population

    Time frame: 3 months

    assessment of presence of hypomanic symptoms, in order to reduce diagnostic mistakes leading to outcome worsening

  2. Hypomanic condition will be defined if the patient will give positive answer to at least 12 items of HCL32. HCL-32-positive patients is expected to be ranged between 4.3% and 21.3%. The difference between the means in the two groups will be estimated.

    Time frame: 3 months

Secondary outcomes

  1. To collect patient characteristics by evaluation of demographic information

    Time frame: 3 months

  2. To collect disease characteristics by evaluation of the number of previous episodes, and the duration of current episode

    Time frame: 3 months

  3. To collect information on the ongoing treatment

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Non - Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient Diagnosed as With Treatment Resistant Major Depressive Disorder (MDD)

Acronym: Improve

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 29, 2011
Registry last updated
Mar 23, 2012

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.

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