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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02535676 |
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Date of registration:
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26/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Schizophrenia TreAtment With electRic Transcranial Stimulation
STARTS |
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Scientific title:
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Treatment of Negative Symptoms of Schizophrenia With Transcranial Direct Current Stimulation (tDCS): A Randomized, Double-blinded, Sham-controlled, Clinical Trial |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02535676 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Leandro Valiengo, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Sao Paulo |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of schizophrenia according to DSM-IV criteria and confirmed by the SCID
- Minimum score of 20 points in the sum of negative PANSS
- Stable antipsychotic medications
Exclusion Criteria:
- Unstable medical illness
- Uncontrolled pretreatment with rTMS or tDCS
- At least six months without being in ECT
- Benzodiazepines in doses of 10mg of diazepam
- Electronic or metal implants in the cephalic segment.
- Other mental disorders and dependence of substances
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Device: Transcranial Direct Current Stimulation
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Primary Outcome(s)
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Change in subscale of PANSS
[Time Frame: Repeated measures: 0, 2, 4 and 6 weeks (endpoint)]
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Secondary Outcome(s)
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Change in Auditory Verbal Hallucination Scale
[Time Frame: Repeated measures: 0, 2, 4, 6 and 12 weeks]
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Change in SANS
[Time Frame: Repeated measures: 0, 2, 4, 6 and 12 weeks]
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Change in Negative subscale of PANSS
[Time Frame: 12 weeks]
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Secondary ID(s)
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31063714.1.1001.0068
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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