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

NCT ID: NCT01344733

Last Updated: 2012-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

660 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depressive Disorder MDD

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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MDD

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Mauro Carta

Role: PRINCIPAL_INVESTIGATOR

A.O.U. Universitaria di Cagliari

Dr. Gino Montagnani

Role: STUDY_CHAIR

Astrazeneca Italy

Dr. Raffaele Sabia

Role: STUDY_DIRECTOR

Astrazeneca Italy

Locations

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Research Site

Agrigento, AG, Italy

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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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Cantù, CO, Italy

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Rogliano, CS, Italy

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Adrano-Bronte, CT, Italy

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Lamezia Terme, 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

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Montecchio Maggiore, VI, Italy

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Castellammare di Stabia, , Italy

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Novara, , Italy

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Countries

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Italy

Other Identifiers

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NIS-NIT-DUM-2010/1

Identifier Type: -

Identifier Source: org_study_id

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