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Treatment of Negative Symptoms and Schizophrenia

NCT ID: NCT02204787

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-01

Study Completion Date

2018-10-26

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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active tDCS

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

Group Type EXPERIMENTAL

transcranial direct current stimulation

Intervention Type DEVICE

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.

Group Type SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

Interventions

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transcranial direct current stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Schizophrenia with prominent negative symptoms

Exclusion Criteria

* other psychiatric or neurological diseases
* specific tDCS limitations
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jerome ATTAL, MD

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Locations

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UH Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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9257

Identifier Type: -

Identifier Source: org_study_id