Clinical trial NCT01315587: Repetitive Transcranial Magnetic Stimulation and Intermittent Theta Burst (iTBS) in Schizophrenia
Official title: A Double-blind Placebo Controlled Trial the Comparison of Effectiveness of Repetitive TMS and iTBS on Negative Symptoms and Cognition in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: University of Tehran
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Outpatients male and female with the range of 18-50 years of age
2. The diagnosis of schizophrenia according to DSM-IV-TR
3. Completion of consent form
4. Being under supervision of a psychiatrist,
5. Being able to adhere to treatment schedule,
6. 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

Exclusion Criteria:

1. The history of rTMS treatment for any reason
2. Cardiac pacemaker
3. Drug pumps
4. Acute heart attack
5. The risk of seizure with any reasons
6. The history of epilepsy or seizure in the first relatives
7. Any metal in head
8. Brain trauma
9. Pregnancy
10. Breastfeeding
11. Drug dependency

Primary outcomes:
measure: Positive and negative syndrome scale ( PANSS )
timeFrame: Change of baseline in negative symptoms at 20 sessions
Secondary outcomes:
measure: Calgary depression for schizophrenia scale (CDSS)
timeFrame: 3 times (Before treatment, session 10, immediately after treatment)
measure: Schizophrenia quality of life scale (SQLS)
timeFrame: 3 times (Before treatment, session 10, immediately after treatment)
measure: Cantab Schizophrenia Battery
timeFrame: 3 times (Before treatment, session 10, immediately after treatment)
measure: QEEG and low resolution brain electromagnetic tomography (LORETA)
timeFrame: 3 times (Before treatment,session 10, immediately after treatment)
Other outcomes:
measure: Hamilton Depression Rating Scale (HAMD-17)
timeFrame: 3 times (Before treatment,session 10, immediately after treatment)
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Atieh Clinical Neuroscience Center (ACNC)
Study officials:
References: