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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01344733
First received: April 21, 2011
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

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.


Condition
Major Depressive Disorder
MDD

Study Type: Observational
Study Design: Time Perspective: Prospective
Official 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)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To define the potential bipolarity status in treatment resistant MDD patient population [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    assessment of presence of hypomanic symptoms, in order to reduce diagnostic mistakes leading to outcome worsening

  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To collect patient characteristics by evaluation of demographic information [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To collect disease characteristics by evaluation of the number of previous episodes, and the duration of current episode [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To collect information on the ongoing treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 660
Study Start Date: May 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
MDD
Patients with treatment resistant major depressive disorder will be evaluated in order to assess the presence of hypomanic symptoms as cause of resistance.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344733

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01344733     History of Changes
Other Study ID Numbers: NIS-NIT-DUM-2010/1
Study First Received: April 21, 2011
Last Updated: March 22, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by AstraZeneca:
Major Depressive Disorder
MDD

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014