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

University of Sao Paulo

Status and phase: Withdrawn; Phase 2

Conditions: Schizophrenia; Transcranial Direct Current Stimulation

Treatments: Procedure: Transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01623726

CAISM-001

Details and patient eligibility

About

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.

Full 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)

Sex: All

Ages: 18 to 59 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

tDCS active

Experimental group

Description:

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

Treatment:

Procedure: Transcranial Direct Current Stimulation (tDCS)

tDCS sham

Placebo Comparator group

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

Treatment:

Procedure: Transcranial Direct Current Stimulation (tDCS)