NCT00875498

Brief Summary

The purpose of this study is to determine whether the iTBS is an effective treatment of the negative symptoms of schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable schizophrenia

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

November 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

6.7 years

First QC Date

April 2, 2009

Last Update Submit

January 26, 2016

Conditions

Schizophrenia

Keywords

iTBSNegative Symptoms

Outcome Measures

Primary Outcomes (1)

  • Scale for the Assessment of Negative Symptoms (SANS)

    before, after 2 weeks of treatment, and 3 times follow-up (1, 3 and 6 months)

Secondary Outcomes (1)

  • Neurochemical impact of treatment measured by 1H-MRS, DTI and resting MRI

    3 times, before treatment, immediatly after treatment and a last evaluation 3 months after

Study Arms (2)

active iTBS

ACTIVE COMPARATOR

iTBS active intensity = 80%MT during 6 minutes. 20 sessions, 2 per day

Procedure: active iTBS

sham iTBS

PLACEBO COMPARATOR

iTBS placebo (placebo coil)with same parameters than active

Procedure: sham iTBS

Interventions

active iTBSPROCEDURE

Intermittent Theta Burst Stimulation (iTBS) over Left dorsolateral prefrontal cortex. 80% MT, 20 sessions of 6 minutes, 2 per day

Also known as: TMS, rTMS, TBS, iTBS
active iTBS
sham iTBSPROCEDURE

iTBS placebo (placebo coil)

Also known as: placebo TMS, placebo rTMS
sham iTBS

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Schizophrenia according to DSM-IV
  • Negative symptoms for at least 6 weeks
  • Medication resistance according to Kane et al., 1988
  • Age between 18 and 50 years old
  • Informed consent

You may not qualify if:

  • Contraindication to TMS
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Le vinatier

Bron, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Emmanuel Poulet, MD, PhD

    Hopital Le Vinatier

    PRINCIPAL INVESTIGATOR

  • JEROME BRUNELIN, PhD

    Hopital le Vinatier

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 2, 2009

First Posted

April 3, 2009

Study Start

November 1, 2008

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

FR(1)