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Treatment of Negative Symptoms and Schizophrenia (STICCS)

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ClinicalTrials.gov Identifier: NCT02204787
Recruitment Status : Recruiting
First Posted : July 30, 2014
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
The aim of this study is to evaluate the therapeutic efficacy of a neuromodulation technique, tDCS (transcranial direct current stimulation) used as a complementary treatment on negative symptoms. 60 patients will be randomized into two groups (active tDCS vs sham tDCS) and will be assessed after the intervention, 1 and 3 months after.Secondary outcomes shall include neuropsychological assessment, general symptomatology, extrapyramidal symptoms and social functioning.

Condition or disease Intervention/treatment Phase
Schizophrenia Device: transcranial direct current stimulation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind Sham Controlled Trial of tDCS for Treatment of Negative Symptoms in Patients With Schizophrenia
Study Start Date : December 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: active tDCS
Transcranial Direct Current Stimulation : 10 sessions twice a day during 5 days, with a 2 mA intensity during 20 minutes.
Device: transcranial direct current stimulation
Sham Comparator: Sham tDCS
Transcranial Direct Current Stimulation : 10 sessions twice a day during 5 days, with a sham stimulation during 20 minutes. Initial stimulation followed by turning off the device as to ensure blinding.
Device: transcranial direct current stimulation



Primary Outcome Measures :
  1. Scale for the Assessment of Negative Symptoms [ Time Frame: up to 3 months after intervention ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Inclusion Criteria:

    • Schizophrenia with prominent negative symptoms
  • Exclusion Criteria:

    • other psychiatric or neurological diseases
    • specific tDCS limitations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204787


Contacts
Contact: Jerome ATTAL, MD 04 67 33 97 02 j-attal@chu-montpellier.fr

Locations
France
UH Montpellier Recruiting
Montpellier, France, 34295
Contact: Jerome ATTAL, MD    04 67 33 97 02    j-attal@chu-montpellier.fr   
Principal Investigator: Jerome ATTAL, MD         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Jerome ATTAL, MD UH Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02204787     History of Changes
Other Study ID Numbers: 9257
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders