NCT01315587

Brief Summary

The pilot studies have showed that theta burst stimulation (TBS) can have the more rapid and durable effects to the apply traditional rTMS protocols. The aim of this study is to investigate the effect of repetitive TMS and theta burst in reduction of negative symptoms and remission of cognitive functioning in patients with schizophrenia. In a randomized, double blind clinical trials, 30 patients with schizophrenia in Razi psychiatric hospital will be assigned to receive repetitive TMS; theta burst, or sham TMS, daily; for 20 sessions. The negative symptoms and cognitive functioning will be assessed before the treatment (pre test) during the treatment (session 10), and after the treatment (post test).QEEG and LORETA apply before and after rTMS in all subjects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_2 schizophrenia

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_2 schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

4.8 years

First QC Date

March 14, 2011

Last Update Submit

August 30, 2015

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Positive and negative syndrome scale ( PANSS )

    Change of baseline in negative symptoms at 20 sessions

Secondary Outcomes (4)

  • Calgary depression for schizophrenia scale (CDSS)

    3 times (Before treatment, session 10, immediately after treatment)

  • Schizophrenia quality of life scale (SQLS)

    3 times (Before treatment, session 10, immediately after treatment)

  • Cantab Schizophrenia Battery

    3 times (Before treatment, session 10, immediately after treatment)

  • QEEG and low resolution brain electromagnetic tomography (LORETA)

    3 times (Before treatment,session 10, immediately after treatment)

Other Outcomes (1)

  • Hamilton Depression Rating Scale (HAMD-17)

    3 times (Before treatment,session 10, immediately after treatment)

Study Arms (3)

intermittent theta burst stimulation

ACTIVE COMPARATOR
Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2 )

repetitive Transcranial Magnetic Stimulation

ACTIVE COMPARATOR
Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2)

Sham TMS

PLACEBO COMPARATOR
Device: repetitive Transcranial Magnetic Stimulation(Magstim rapid2)

Interventions

repetitive Transcranial Magnetic Stimulation (Magstim rapid2)DEVICE

LDLPFC 110% MT 15 Hz 20 days

Also known as: TMS, rTMS
repetitive Transcranial Magnetic Stimulation
repetitive Transcranial Magnetic Stimulation(Magstim rapid2)DEVICE

Placebo treatment: Sham coil

Sham TMS

Eligibility Criteria

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

You may qualify if:

  • Outpatients male and female with the range of 18-50 years of age
  • The diagnosis of schizophrenia according to DSM-IV-TR
  • Completion of consent form
  • Being under supervision of a psychiatrist,
  • Being able to adhere to treatment schedule,
  • Having stable symptoms as defined by not requiring a change in antipsychotic medication for at least 4 weeks or at least 2 weeks for psychotropic agents prior to entering the Study

You may not qualify if:

  • The history of rTMS treatment for any reason
  • Cardiac pacemaker
  • Drug pumps
  • Acute heart attack
  • The risk of seizure with any reasons
  • The history of epilepsy or seizure in the first relatives
  • Any metal in head
  • Brain trauma
  • Pregnancy
  • Breastfeeding
  • Drug dependency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atieh Clinical Neuroscience Center (ACNC)

Tehran, Tehran Province, 1969713663, Iran

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Reza kazemi, PhD

CONTACT

009802184012128rezakazemi@ut.ac.ir

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 15, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2015

Study Completion

January 1, 2017

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

IR(1)