Clinical trial NCT01623726: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Transcranial Direct Current Stimulation
Schizophrenia
Keywords: Transcranial Direct Current Stimulation
Schizophrenia
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Negative Symptoms Rates as assessed by the PAANS
timeFrame: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Positive and Negative Syndrome Scale (PAANS)
Secondary outcomes:
measure: Mental Mini Exam
timeFrame: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive Screening assessment as performed by the Mental Mini Exam
measure: Moca rating Scale
timeFrame: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by MoCa Test
measure: Stroop Victoria
timeFrame: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by Stroop - Victoria version
measure: Neuropsychological Assessment
timeFrame: Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - neuropsychologial assessment by trained researcher
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Centro de Atenção Integrada à Saúde Mental
state: SP
Study officials:
affiliation: Irmandade da Santa Casa de Misericórdia de São Paulo
name: Andre R Brunoni, PhD
role: STUDY_CHAIR
affiliation: Irmandade da Santa Casa de Misericóridia de São Paulo
name: Pedro Shiozawa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Irmandade da Santa Casa de Misericórdia de São Paulo
name: Quirino Jr Cordeiro, PhD
role: STUDY_DIRECTOR
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