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NCT01872143 Clinical Trial

Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders

Mental Disorders Clinical Trial

Official title:
Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01872143
Other study ID # 61/10 (Ethical Committee)
Secondary ID
Status Recruiting
Phase Phase 2
First received May 16, 2013
Last updated June 3, 2013
Start date May 2013
Est. completion date May 2014

Study information
Verified date June 2013
Source Federico II University
Contact giordano d'urso, MD, PhD
Phone +390817462652
Email giordanodurso@me.com
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in the treatment of psychiatric disorders in which available treatments are either ineffective or not tolerated

Description:

Depending on the specific psychiatric disorder, inhibitory or stimulating neuromodulation will be applied over the cortical region of interest, found according to the relevant scientific publication on neurophysiology of psychiatric disorders

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- a psychiatric disorder in which available treatment are either ineffective or not tolerated

Exclusion Criteria:

- implantable active devices

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• transcranial Direct Current Stimulation
daily or twice-a-day administration of transcranial Direct Current Stimulation from a minimum of 10 session to a maximum of 20

Locations
Country Name City State
Italy AOU "Federico II" of Naples Naples

Sponsors (1)
Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline Psychiatric rating scales scores at immediate post-treatment and at one-month and at three-month follow-up visits Time points: T0=baseline; T1=immediate post-treatment; T2=one-month follow-up visit; T3=3-months follow-up visit No
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