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Transcranial Direct Current Stimulation (tDCS) as Therapeutical Strategy for Negative Symptoms in Schizophrenia

Primary Purpose

Transcranial Direct Current Stimulation, Schizophrenia

Status
Withdrawn
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transcranial Direct Current Stimulation focused on measuring Transcranial Direct Current Stimulation, Schizophrenia

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with age between 18-59 years
  • diagnostic of Schizophrenia or Schizoaffective Disorder as stated by DSM-IV and confirmed by SCID (Structured Clinical Interview for DSMIV), to be tested by a psychiatrist
  • baseline score higher than 20 for negative symptoms at PAAN
  • patients able to read and understand Portuguese.

Exclusion Criteria:

  • other psychiatric diagnosis
  • criteria for bipolar disorder; dementia; other psychotic disturbs; substance related disorders
  • presence of other severe neurological or clinical diseases
  • presence of suicidal behavior (planning or attempt in the previous 4 weeks)
  • pregnancy
  • incapacity of coping with the informed consent
  • specific tDCS limitations (such as anatomic problems)

Regarding medication: all patients should have stable dosology of medications for at least 6 weeks

Sites / Locations

  • Centro de Atenção Integrada à Saúde Mental

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tDCS active

tDCS sham

Arm Description

Active tDCS as foreseen in research protocol: daily sessions for 10 days with 2mA intensity stimulation during 20 minutes.

Sham tDCS : as foreseen in research protocol: sham stimulation with initial stimulation followed by turning off the device during the same time of intervention as to guarantee blinding

Outcomes

Primary Outcome Measures

Negative Symptoms Rates as assessed by the PAANS
Comparison between follow u and baseline PAANS scores with emphasis in negative symptoms scores

Secondary Outcome Measures

Mental Mini Exam
cognitive evaluation as assessed by the Mental Mini Exam
Moca rating Scale
comparison between follow up and baseline scores in Cognitive evaluation as assessed by MoCa Test
Stroop Victoria
comparison between follow up and baseline scores in atention and inhibitory control as assessed by Stroop Victoria
Neuropsychological Assessment
comparison between follow up and baseline scores in neuropschological evaluations performed by specialist using SuperLab tool

Full Information

First Posted
June 8, 2012
Last Updated
December 13, 2013
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01623726
Brief Title
Transcranial Direct Current Stimulation (tDCS) as Therapeutical Strategy for Negative Symptoms in Schizophrenia
Official Title
Transcranial Direct Current Stimulation (tDCS) as Therapeutical Strategy for Negative Symptoms in Schizophrenia: a Double-blind Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Withdrawn
Why Stopped
To be submitted for grant application
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The current research is aimed at using Transcranial Direct Current Stimulation (tDCS) as complementary therapeutic tool in the treatment of schizophrenia. Patients will be randomized into two groups (tDCS-active x tDCS-sham) accordingly to detailed protocol. Main outcome will be measured by specific clinical rating scales based on the assessment of negative symptoms. A total of 40 patients ought to be enrolled as specified in methodology. Secondary outcomes shall include collateral effects evaluation, anxiety and depressive scales as well as clinical monitoring.
Detailed Description
Overview The present study is a double-blind randomized clinical trial in which patients should be allocated from a General Psychiatry Service into two groups (tDCS-active x tDCS-sham). Subjects who fulfilled eligibility criteria will undergo ten days of consecutive stimulation (active or sham) and will return after two to four weeks for final clinical assessment. Patients who shown no response in rating scales and that were allocated to sham intervention group will be able to choose whether or not they want to undergo the active intervention at follow up (partial cross-over)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Direct Current Stimulation, Schizophrenia
Keywords
Transcranial Direct Current Stimulation, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS active
Arm Type
Experimental
Arm Description
Active tDCS as foreseen in research protocol: daily sessions for 10 days with 2mA intensity stimulation during 20 minutes.
Arm Title
tDCS sham
Arm Type
Placebo Comparator
Arm Description
Sham tDCS : as foreseen in research protocol: sham stimulation with initial stimulation followed by turning off the device during the same time of intervention as to guarantee blinding
Intervention Type
Procedure
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Intervention Description
Transcranial Direct Current Stimulation. Daily sessions with a total of 10 days intervention. Each intervention will take place with a 2mA intensity during 20 minutes. The current will be delivered by "Chattanooga Iontophoresis Dual Channel Delivery Device", that stands for a 2-channels tDCS device in which previous dosage can be set as default to maintain frequently used treatment parameters. Main features include (a) Beeping alerts if electrode fault for open current or high impedance, low battery, treatment completion or power left on; (b)automatic 30 second current ramp up and down during power on/off keeps patient comfortable; (c) Current can be set in 0.1 mA increments between 0.5 mA and 4 mA.
Primary Outcome Measure Information:
Title
Negative Symptoms Rates as assessed by the PAANS
Description
Comparison between follow u and baseline PAANS scores with emphasis in negative symptoms scores
Time Frame
Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Positive and Negative Syndrome Scale (PAANS)
Secondary Outcome Measure Information:
Title
Mental Mini Exam
Description
cognitive evaluation as assessed by the Mental Mini Exam
Time Frame
Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive Screening assessment as performed by the Mental Mini Exam
Title
Moca rating Scale
Description
comparison between follow up and baseline scores in Cognitive evaluation as assessed by MoCa Test
Time Frame
Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by MoCa Test
Title
Stroop Victoria
Description
comparison between follow up and baseline scores in atention and inhibitory control as assessed by Stroop Victoria
Time Frame
Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by Stroop - Victoria version
Title
Neuropsychological Assessment
Description
comparison between follow up and baseline scores in neuropschological evaluations performed by specialist using SuperLab tool
Time Frame
Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - neuropsychologial assessment by trained researcher

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with age between 18-59 years diagnostic of Schizophrenia or Schizoaffective Disorder as stated by DSM-IV and confirmed by SCID (Structured Clinical Interview for DSMIV), to be tested by a psychiatrist baseline score higher than 20 for negative symptoms at PAAN patients able to read and understand Portuguese. Exclusion Criteria: other psychiatric diagnosis criteria for bipolar disorder; dementia; other psychotic disturbs; substance related disorders presence of other severe neurological or clinical diseases presence of suicidal behavior (planning or attempt in the previous 4 weeks) pregnancy incapacity of coping with the informed consent specific tDCS limitations (such as anatomic problems) Regarding medication: all patients should have stable dosology of medications for at least 6 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre R Brunoni, PhD
Organizational Affiliation
Irmandade da Santa Casa de Misericórdia de São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pedro Shiozawa, MD
Organizational Affiliation
Irmandade da Santa Casa de Misericóridia de São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Quirino Jr Cordeiro, PhD
Organizational Affiliation
Irmandade da Santa Casa de Misericórdia de São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Atenção Integrada à Saúde Mental
City
São Paulo
State/Province
SP
ZIP/Postal Code
01415001
Country
Brazil

12. IPD Sharing Statement

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Transcranial Direct Current Stimulation (tDCS) as Therapeutical Strategy for Negative Symptoms in Schizophrenia

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