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Treatment of Negative Symptoms and Schizophrenia (STICCS)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

  • Inclusion Criteria:

    • Schizophrenia with prominent negative symptoms

  • Exclusion Criteria:

    • other psychiatric or neurological diseases
    • specific tDCS limitations

Sites / Locations

  • UH Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

active tDCS

Sham tDCS

Arm Description

Transcranial Direct Current Stimulation : 10 sessions twice a day during 5 days, with a 2 mA intensity during 20 minutes.

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.

Outcomes

Primary Outcome Measures

Scale for the Assessment of Negative Symptoms

Secondary Outcome Measures

Full Information

First Posted
July 29, 2014
Last Updated
December 13, 2022
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02204787
Brief Title
Treatment of Negative Symptoms and Schizophrenia
Acronym
STICCS
Official Title
A Double Blind Sham Controlled Trial of tDCS for Treatment of Negative Symptoms in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
October 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active tDCS
Arm Type
Experimental
Arm Description
Transcranial Direct Current Stimulation : 10 sessions twice a day during 5 days, with a 2 mA intensity during 20 minutes.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Primary Outcome Measure Information:
Title
Scale for the Assessment of Negative Symptoms
Time Frame
up to 3 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Schizophrenia with prominent negative symptoms Exclusion Criteria: other psychiatric or neurological diseases specific tDCS limitations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerome ATTAL, MD
Organizational Affiliation
UH Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Learn more about this trial

Treatment of Negative Symptoms and Schizophrenia

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