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

Phase 2

Withdrawn

• Conditions: Transcranial Direct Current Stimulation; Schizophrenia
• Interventions: Procedure: Transcranial Direct Current Stimulation (tDCS)

• Registration Number: NCT01623726
• Lead Sponsor: University of Sao Paulo

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)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-06-15
• Study First Posted: 2012-06-20
• Study Start: 2012-08
• Primary Completion: 2013-08
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-13
• Last Update Posted: 2013-12-16
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tDCS sham	Transcranial Direct Current Stimulation (tDCS)	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
tDCS active	Transcranial Direct Current Stimulation (tDCS)	Active tDCS as foreseen in research protocol: daily sessions for 10 days with 2mA intensity stimulation during 20 minutes.

Primary Outcome Measures

Name	Time	Method
Negative Symptoms Rates as assessed by the PAANS	Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Positive and Negative Syndrome Scale (PAANS)	Comparison between follow u and baseline PAANS scores with emphasis in negative symptoms scores

Secondary Outcome Measures

Name	Time	Method
Mental Mini Exam	Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive Screening assessment as performed by the Mental Mini Exam	cognitive evaluation as assessed by the Mental Mini Exam
Moca rating Scale	Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by MoCa Test	comparison between follow up and baseline scores in Cognitive evaluation as assessed by MoCa Test
Stroop Victoria	Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by Stroop - Victoria version	comparison between follow up and baseline scores in atention and inhibitory control as assessed by Stroop Victoria
Neuropsychological Assessment	Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - neuropsychologial assessment by trained researcher	comparison between follow up and baseline scores in neuropschological evaluations performed by specialist using SuperLab tool

Trial Locations

Locations (1)

Centro de Atenção Integrada à Saúde Mental; 🇧🇷 São Paulo, SP, Brazil