Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01344733
Other study ID # NIS-NIT-DUM-2010/1
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05537558 - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated NCT02192099 - Open Label Extension for GLYX13-C-202, NCT01684163 Phase 2
Completed NCT03142919 - Lipopolysaccharide (LPS) Challenge in Depression Phase 2
Recruiting NCT05547035 - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders N/A
Terminated NCT02940769 - Neurobiological Effects of Light on MDD N/A
Recruiting NCT05892744 - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression Phase 4
Recruiting NCT05537584 - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment Phase 4
Active, not recruiting NCT05061706 - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder Phase 3
Completed NCT04479852 - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder Phase 2
Recruiting NCT04032301 - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans Phase 1
Recruiting NCT05527951 - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study N/A
Completed NCT03511599 - Cycloserine rTMS Plasticity Augmentation in Depression Phase 1
Recruiting NCT04392947 - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation N/A
Recruiting NCT05895747 - 5-HTP and Creatine for Depression R33 Phase Phase 2
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Recruiting NCT05813093 - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression N/A
Recruiting NCT05135897 - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation NCT04509102 - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder Early Phase 1
Recruiting NCT06026917 - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET) Phase 4
Recruiting NCT06145594 - EMA-Guided Maintenance TMS for Depression N/A