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

Major Depressive Disorder Clinical Trial

— Improve  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344733
• Other study ID #: NIS-NIT-DUM-2010/1
• Status: Completed
• Phase: N/A
• First received: April 21, 2011
• Last updated: March 22, 2012
• Start date: May 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• MDD

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	To collect patient characteristics by evaluation of demographic information		3 months	No
Secondary	To collect disease characteristics by evaluation of the number of previous episodes, and the duration of current episode		3 months	No
Secondary	To collect information on the ongoing treatment		3 months	No