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

Completed

• Conditions: Major Depressive Disorder; MDD

• Registration Number: NCT01344733
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Study Start: 2011-05
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-22
• Last Update Posted: 2012-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇮🇹 Novara, Italy