NCT01872143

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 7, 2013

Status Verified

June 1, 2013

Enrollment Period

1 year

First QC Date

May 16, 2013

Last Update Submit

June 3, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

transcranial Direct Current Stimulation

EXPERIMENTAL

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

Device: transcranial Direct Current Stimulation

Interventions

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

transcranial Direct Current Stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • implantable active devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU "Federico II" of Naples

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • giordano d'urso, MD, PhD

    AOU "Federico II" of Naples

    PRINCIPAL INVESTIGATOR

Central Study Contacts

giordano d'urso, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 16, 2013

First Posted

June 7, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 7, 2013

Record last verified: 2013-06

Locations