Clinical trial NCT01344733: A Non Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient With Major Depressive Disorder (MDD)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
MDD
Keywords: Major Depressive Disorder
MDD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-04-29
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility 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

Primary outcomes:
measure: To define the potential bipolarity status in treatment resistant MDD patient population
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
Secondary outcomes:
measure: To collect patient characteristics by evaluation of demographic information
timeFrame: 3 months
measure: To collect disease characteristics by evaluation of the number of previous episodes, and the duration of current episode
timeFrame: 3 months
measure: To collect information on the ongoing treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Agrigento
country: Italy
facility: Research Site
state: AG
city: Sciacca
country: Italy
facility: Research Site
state: AG
city: Ancona
country: Italy
facility: Research Site
state: AN
city: Corato
country: Italy
facility: Research Site
state: BA
city: Putignano
country: Italy
facility: Research Site
state: BA
city: Triggiano
country: Italy
facility: Research Site
state: BA
city: Fasano
country: Italy
facility: Research Site
state: BR
city: Bolzano
country: Italy
facility: Research Site
state: BZ
city: Cagliari
country: Italy
facility: Research Site
state: CA
city: Ortona
country: Italy
facility: Research Site
state: CH
city: Cantu
country: Italy
facility: Research Site
state: CO
city: Rogliano
country: Italy
facility: Research Site
state: CS
city: Adrano-Bronte
country: Italy
facility: Research Site
state: CT
city: Lamezia
country: Italy
facility: Research Site
state: CZ
city: Foggia
country: Italy
facility: Research Site
state: FG
city: Firenze- ASL di Firenze
country: Italy
facility: Research Site
state: FI
city: Genova
country: Italy
facility: Research Site
state: GE
city: Latina
country: Italy
facility: Research Site
state: LT
city: Messina
country: Italy
facility: Research Site
state: ME
city: Rho
country: Italy
facility: Research Site
state: MI
city: Corleone
country: Italy
facility: Research Site
state: PA
city: Palermo
country: Italy
facility: Research Site
state: PA
city: Guidonia
country: Italy
facility: Research Site
state: RM
city: Roma
country: Italy
facility: Research Site
state: RM
city: Capaccio
country: Italy
facility: Research Site
state: SA
city: Savona
country: Italy
facility: Research Site
state: SA
city: Montecchio Maggiore
country: Italy
facility: Research Site
state: VI
city: Castellammare di Stabia
country: Italy
facility: Research Site
city: Novara
country: Italy
facility: Research Site
Study officials:
affiliation: A.O.U. Universitaria di Cagliari
name: Dr. Mauro Carta
role: PRINCIPAL_INVESTIGATOR
affiliation: Astrazeneca Italy
name: Dr. Gino Montagnani
role: STUDY_CHAIR
affiliation: Astrazeneca Italy
name: Dr. Raffaele Sabia
role: STUDY_DIRECTOR
References: