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

Schizophrenia Clinical Trial

Official title:

Transcranial Direct Current Stimulation (tDCS) as Therapeutical Strategy for Negative Symptoms in Schizophrenia: a Double-blind Randomized Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01623726
• Other study ID #: CAISM-001
• Status: Withdrawn
• Phase: Phase 2
• First received: June 8, 2012
• Last updated: December 13, 2013
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: December 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia
• Transcranial Direct Current Stimulation

Intervention

Procedure:
• Transcranial Direct Current Stimulation (tDCS)
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.

Locations

Country	Name	City	State
Brazil	Centro de Atenção Integrada à Saúde Mental	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (16)

Andrade L, Caraveo-Anduaga JJ, Berglund P, Bijl RV, De Graaf R, Vollebergh W, Dragomirecka E, Kohn R, Keller M, Kessler RC, Kawakami N, Kiliç C, Offord D, Ustun TB, Wittchen HU. The epidemiology of major depressive episodes: results from the International Consortium of Psychiatric Epidemiology (ICPE) Surveys. Int J Methods Psychiatr Res. 2003;12(1):3-21. Erratum in: Int J Methods Psychiatr Res. 2003;12(3):165. — View Citation

Andreasen NC. Symptoms, signs, and diagnosis of schizophrenia. Lancet. 1995 Aug 19;346(8973):477-81. Review. — View Citation

Awad AG, Voruganti LN. The burden of schizophrenia on caregivers: a review. Pharmacoeconomics. 2008;26(2):149-62. Review. — View Citation

BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. — View Citation

Benseñor IM, Brunoni AR, Pilan LA, Goulart AC, Busatto GF, Lotufo PA, Scazufca M, Menezes PR. Cardiovascular risk factors in patients with first-episode psychosis in São Paulo, Brazil. Gen Hosp Psychiatry. 2012 May-Jun;34(3):268-75. doi: 10.1016/j.genhosppsych.2011.12.010. Epub 2012 Feb 2. — View Citation

Boggio PS, Rigonatti SP, Ribeiro RB, Myczkowski ML, Nitsche MA, Pascual-Leone A, Fregni F. A randomized, double-blind clinical trial on the efficacy of cortical direct current stimulation for the treatment of major depression. Int J Neuropsychopharmacol. 2008 Mar;11(2):249-54. Epub 2007 Jun 11. — View Citation

Bressan RA, Chaves AC, Pilowsky LS, Shirakawa I, Mari JJ. Depressive episodes in stable schizophrenia: critical evaluation of the DSM-IV and ICD-10 diagnostic criteria. Psychiatry Res. 2003 Jan 25;117(1):47-56. — View Citation

Brunoni AR, Ferrucci R, Fregni F, Boggio PS, Priori A. Transcranial direct current stimulation for the treatment of major depressive disorder: a summary of preclinical, clinical and translational findings. Prog Neuropsychopharmacol Biol Psychiatry. 2012 Oct 1;39(1):9-16. doi: 10.1016/j.pnpbp.2012.05.016. Epub 2012 May 28. Review. — View Citation

Brunoni AR, Teng CT, Correa C, Imamura M, Brasil-Neto JP, Boechat R, Rosa M, Caramelli P, Cohen R, Del Porto JA, Boggio PS, Fregni F. Neuromodulation approaches for the treatment of major depression: challenges and recommendations from a working group meeting. Arq Neuropsiquiatr. 2010 Jun;68(3):433-51. Review. — View Citation

Davey NJ, Smith HC, Savic G, Maskill DW, Ellaway PH, Frankel HL. Comparison of input-output patterns in the corticospinal system of normal subjects and incomplete spinal cord injured patients. Exp Brain Res. 1999 Aug;127(4):382-90. — View Citation

Fregni F, Pascual-Leone A. Technology insight: noninvasive brain stimulation in neurology-perspectives on the therapeutic potential of rTMS and tDCS. Nat Clin Pract Neurol. 2007 Jul;3(7):383-93. Review. — View Citation

Loranger AW. Sex difference in age at onset of schizophrenia. Arch Gen Psychiatry. 1984 Feb;41(2):157-61. — View Citation

McGlashan TH, Johannessen JO. Early detection and intervention with schizophrenia: rationale. Schizophr Bull. 1996;22(2):201-22. Review. — View Citation

Nitsche MA, Boggio PS, Fregni F, Pascual-Leone A. Treatment of depression with transcranial direct current stimulation (tDCS): a review. Exp Neurol. 2009 Sep;219(1):14-9. doi: 10.1016/j.expneurol.2009.03.038. Epub 2009 Apr 5. Review. — View Citation

Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1. Review. — View Citation

Wagner T, Fregni F, Fecteau S, Grodzinsky A, Zahn M, Pascual-Leone A. Transcranial direct current stimulation: a computer-based human model study. Neuroimage. 2007 Apr 15;35(3):1113-24. Epub 2007 Feb 4. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative Symptoms Rates as assessed by the PAANS	Comparison between follow u and baseline PAANS scores with emphasis in negative symptoms scores	Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Positive and Negative Syndrome Scale (PAANS)	No
Secondary	Mental Mini Exam	cognitive evaluation as assessed by the Mental Mini Exam	Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive Screening assessment as performed by the Mental Mini Exam	No
Secondary	Moca rating Scale	comparison between follow up and baseline scores in Cognitive evaluation as assessed by MoCa Test	Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by MoCa Test	No
Secondary	Stroop Victoria	comparison between follow up and baseline scores in atention and inhibitory control as assessed by Stroop Victoria	Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - Cognitive assessment by Stroop - Victoria version	No
Secondary	Neuropsychological Assessment	comparison between follow up and baseline scores in neuropschological evaluations performed by specialist using SuperLab tool	Assessment at 0(baseline), 2 weeks and 4 weeks (final outcome) - neuropsychologial assessment by trained researcher	No