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

A Non - Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient Diagnosed as With Treatment Resistant 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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder; MDD

• Study Type: Observational
• Enrollment (Actual): 660

Contacts and Locations

Study Locations

• Italy
  • Castellammare di Stabia, Italy
    • Research Site
  • Novara, Italy
    • Research Site
  • AG
    • Agrigento, AG, Italy
      • Research Site
    • Sciacca, AG, Italy
      • Research Site
  • AN
    • Ancona, AN, Italy
      • Research Site
  • BA
    • Corato, BA, Italy
      • Research Site
    • Putignano, BA, Italy
      • Research Site
    • Triggiano, BA, Italy
      • Research Site
  • BR
    • Fasano, BR, Italy
      • Research Site
  • BZ
    • Bolzano, BZ, Italy
      • Research Site
  • CA
    • Cagliari, CA, Italy
      • Research Site
  • CH
    • Ortona, CH, Italy
      • Research Site
  • CO
    • Cantu, CO, Italy
      • Research Site
  • CS
    • Rogliano, CS, Italy
      • Research Site
  • CT
    • Adrano-Bronte, CT, Italy
      • Research Site
  • CZ
    • Lamezia, CZ, Italy
      • Research Site
  • FG
    • Foggia, FG, Italy
      • Research Site
  • FI
    • Firenze- ASL di Firenze, FI, Italy
      • Research Site
  • GE
    • Genova, GE, Italy
      • Research Site
  • LT
    • Latina, LT, Italy
      • Research Site
  • ME
    • Messina, ME, Italy
      • Research Site
  • MI
    • Rho, MI, Italy
      • Research Site
  • PA
    • Corleone, PA, Italy
      • Research Site
    • Palermo, PA, Italy
      • Research Site
  • RM
    • Guidonia, RM, Italy
      • Research Site
    • Roma, RM, Italy
      • Research Site
  • SA
    • Capaccio, SA, Italy
      • Research Site
    • Savona, SA, Italy
      • Research Site
  • VI
    • Montecchio Maggiore, VI, Italy
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with treatment resistant major depressive disorder will be evaluated in order to assess the presence of hypomanic symptoms as cause of resistance.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
MDD; Patients with treatment resistant major depressive disorder will be evaluated in order to assess the presence of hypomanic symptoms as cause of resistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To define the potential bipolarity status in treatment resistant MDD patient population	assessment of presence of hypomanic symptoms, in order to reduce diagnostic mistakes leading to outcome worsening	3 months
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.		3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To collect patient characteristics by evaluation of demographic information	3 months
To collect disease characteristics by evaluation of the number of previous episodes, and the duration of current episode	3 months
To collect information on the ongoing treatment	3 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Dr. Mauro Carta, A.O.U. Universitaria di Cagliari; Study Chair: Dr. Gino Montagnani, Astrazeneca Italy; Study Director: Dr. Raffaele Sabia, Astrazeneca Italy

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: April 21, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimate): April 29, 2011

Study Record Updates

• Last Update Posted (Estimate): March 23, 2012
• Last Update Submitted That Met QC Criteria: March 22, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: MDD; Major Depressive Disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major
• Other Study ID Numbers: NIS-NIT-DUM-2010/1