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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.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: April 21, 2011
Last updated: March 22, 2012
Last verified: March 2012
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.

Major Depressive Disorder

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 ]
    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 ]

Secondary Outcome Measures:
  • To collect patient characteristics by evaluation of demographic information [ Time Frame: 3 months ]
  • To collect disease characteristics by evaluation of the number of previous episodes, and the duration of current episode [ Time Frame: 3 months ]
  • To collect information on the ongoing treatment [ Time Frame: 3 months ]

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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

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 identifier: NCT01344733

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

Responsible Party: AstraZeneca 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

Keywords provided by AstraZeneca:
Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms processed this record on May 22, 2017