Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders

Phase 2

• Conditions: Mental Disorders
• Interventions: Device: transcranial Direct Current Stimulation

• Registration Number: NCT01872143
• Lead Sponsor: Federico II University

Brief 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

Detailed 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

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-16
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-03
• Last Update Submitted: 2013-06-03
• Study First Posted: 2013-06-07
• Last Update Posted: 2013-06-07
• Primary Completion: 2014-05
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• implantable active devices

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
transcranial Direct Current Stimulation	transcranial Direct Current Stimulation	daily or twice-a-day administration of transcranial Direct Current Stimulation

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

AOU "Federico II" of Naples; 🇮🇹 Naples, Italy