Clinical trial NCT03649685: Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Obsessive Compulsive Disorder
Official title: A Randomized Clinical Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Obsessive-Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Shanghai 10th People's Hospital
First posted: 2018-08-28
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the possible therapeutic effects of repetitive transcranial magnetic stimulation(rTMS) in obsessive-compulsive disorder (OCD) in OCD patients who have not fully responded to pharmacotherapy, and the underlying neural mechanism by EEG.

Detailed description: The purpose of study is to examine the efficacy of rTMS over different brain areas, including the bilateral supplement motor Area (SMA), the right dorsal lateral prefrontal cortex (DLPFC) and SMA+DLPFC in the treatment of OCD. 120 OCD patients will be randomized into four groups. Continuous theta burst stimulation (cTBS) stimulation will be performed once a day, five times a week, for four weeks. The investigators will assess improvement after four weeks of cTBS. Though the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS), the Barratt Impulsiveness Scale-11 (BIS-11), the Beck Depression Inventory(BDI), the Beck Anxiety Inventory (BAI), Perceived Stress Scale(PSS), Pittsburgh sleep quality index(PSQI), the Obsessive-Compulsive Inventory-Revised(OCI-R) and side effects will be obtained by a trained investigator. The patients will also receive magnetic resonance imaging scan and electroencephalography (EEG).

Eligibility criteria: Inclusion Criteria:

* age\>18 years old;
* DSM-5 criteria for OCD;
* Y-BOCS total score \> or = 16, despite treatment with an adequate trial of a serotonin reuptake inhibitor (SRI) and currently using adequate, stable dose of SRI at least 4 weeks. An adequate SRI trial is defined as treatment for at least 12 weeks on the SRI, that meets or exceeds the recommended dosage level for OCD;
* \>or＝9 yrs education

Exclusion Criteria:

* any additional current psychiatric comorbidity, except for obsessive-compulsive personality disorder
* serious suicide risk;
* the inability to receive rTMS because of metallic implants, or history of seizures，or history of head injury, or history of neurosurgery;
* any major medical disease;
* pregnancy or nursing of an infant;
* participation in current clinical study;
* current use of any investigational drug;
* TMS/DBS treatment at any point in their lifetime;
* history of long-time use of benzodiazepines

Primary outcomes:
measure: Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale
timeFrame: Up to 6 months
Secondary outcomes:
measure: The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS)
timeFrame: Up to 6 months
measure: The Barratt Impulsiveness Scale-11 (BIS-11)
timeFrame: Up to 6 months
measure: The Beck Depression Inventory(BDI)
timeFrame: Up to 6 months
measure: The Beck Anxiety Inventory (BAI)
timeFrame: Up to 6 months
measure: State-trait Anxiety Inventory(STAI)
timeFrame: Up to 6 months
measure: Perceived Stress Scale(PSS)
timeFrame: Up to 6 months
measure: Pittsburgh sleep quality index(PSQI)
timeFrame: Up to 6 months
measure: The Obsessive-Compulsive Inventory-Revised(OCI-R)
timeFrame: Up to 6 months
measure: side effects
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Zhen Wang, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: