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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01344733

Acronym

Improve

Enrollment

660

Registered

2011-04-29

Start date

2011-05-31

Completion date

2012-03-31

Last updated

2012-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder, MDD

Keywords

Major Depressive Disorder, MDD

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
To define the potential bipolarity status in treatment resistant MDD patient population	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.	3 months	—

Secondary

Measure	Time frame
To collect patient characteristics by evaluation of demographic information	3 months
To collect disease characteristics by evaluation of the number of previous episodes, and the duration of current episode	3 months
To collect information on the ongoing treatment	3 months

Countries

Italy

Outcome results