NCT01378078

Brief Summary

Transcranial direct current stimulation (tDCS) showed beneficial effects on cognition in healthy subjects and depressed patients. In this study, patients with treatment resistant negative syndrome in schizophrenia will be treated with direct current stimulation. fMRI measures will be performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 22, 2013

Status Verified

July 1, 2013

Enrollment Period

2 years

First QC Date

June 16, 2011

Last Update Submit

July 19, 2013

Conditions

Schizophrenia

Keywords

schizophrenianegative syndromePANSS

Outcome Measures

Primary Outcomes (1)

  • SANS reduction

    decrease by 30%

    4 weeks after baseline

Secondary Outcomes (1)

  • neuropsychological tests

    4 weeks after baseline

Study Arms (2)

sham

SHAM COMPARATOR

patients receive sham tDCS stimulation

Device: eldith DC-stimulator (neuroconn, Ilmenau, Germany)

active

ACTIVE COMPARATOR

active transcranial direct current stimulation

Device: eldith DC-stimulator (Neuroconn, Ilmenau, Germany)

Interventions

eldith DC-stimulator (Neuroconn, Ilmenau, Germany)DEVICE

daily tDCS treatment over left DLPFC, 20 min, 2 mA

sham

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • schizophrenic patients with a negative syndrome. PANSS \> 40.

You may not qualify if:

  • other psychiatric or neurologic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik fuer Psychiatrie

Munich, 80336, Germany

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Ulrich Palm, MD

    Ludwig Maximilian University Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 22, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 22, 2013

Record last verified: 2013-07

Locations

DE(1)