Generalized Anxiety Disorder patients Generalized Anxiety Disorder GAD TMS rTMS Transcranial magnetic stimulation
Conditions
Interventions
rTMS is performed by using Magstim Rapid2 with total 30 sessions. rTMS is performed 5 sessions/week for 6 weeks. The allowable duration between sessions is no longer than 4 days. In each session, 1-Hz
symptoms or psychotherapy.
Experimental Device,Active Comparator Other
Repetitive Transcranial Magnetic Stimulation,Control group (Standard of care)
Sponsors
Siriraj Research Fund
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patient with Generalized Anxiety Disorder according to DSM-5 who is interviewed by psychiatrists or psychiatric residents and confirmed by M.I.N.I. 2. Hamilton anxiety rating scale (HAM-A) at least 18 3. Montgomery and Asberg Depression Rating Scale (MADRS) < 20 4. Stable dose of medication treating GAD except for benzodiazepine drugs as needed
Exclusion criteria
Exclusion criteria: 1. Contraindication for rTMS which are history of seizure, using implant pacemaker, using cochlear implant, using metallic implant, using ocular implant and having aneurysmal clip or stent 2. Psychosis within 1 months before participating in research 3. High risk for suicide within 1 months before participating in research 4. Unstable medical condition such as heart failure, coronary heart disease, ischemic or hemorrhagic stroke, or bone fracture 5.Alcohol use disorder/sedative use disorder with acutely abstinent within 1 week before participating in research 6. Cannot use Thai language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (Anxiety) at 30 sessions after rTMS or 6 weeks Reduction of Hamilton Anxiety Rating Scale (HAM-A) at least 50% | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission rate at 30 sessions after rTMS or 6 weeks HAM-A less than 8 ,Anxiety at 10, 20, 30 sessions after rTMS or 2, 4, 6 weeks and follow up at 10 and 18 weeks Change in HAM-A,Anxiety at 10, 20, 30 sessions after rTMS or 2, 4, 6 weeks and follow up at 10 and 18 weeks GAD-7,Depression at 10, 20, 30 sessions after rTMS or 2, 4, 6 weeks and follow up at 10 and 18 weeks Montgomery-Asberg Depression Rating Scale (MADRS) ,Global impression at 10, 20, 30 sessions after rTMS or 2, 4, 6 weeks and follow up at 10 and 18 weeks Clinical Global Impression - Severity scale (CGI-S),Global impression of improvement at 10, 20, 30 sessions after rTMS or 2, 4, 6 weeks and follow up at 10 and 18 weeks Clinical Global Impression of Improvement (CGI-I),Cognitive function at 10, 20, 30 sessions after rTMS or 2, 4, 6 weeks and follow up at 10 and 18 weeks Thai Mental Status Examination (TMSE), ,Executive function at 10, 20, 30 sessions after rTMS or 2, 4, 6 weeks and follow up at 10 and 18 weeks Digit Symbol Substitution Test (DSST) ,Sleep quality at 10, 20, 30 sessions after rTMS or 2, 4, 6 weeks and follow up at 10 and 18 weeks Pittsburgh Sleep Quality Index (PSQI) ,Adverse effect at 10, 20, 30 sessions after rTMS or 2, 4, 6 weeks and follow up at 10 and 18 weeks Reporting | — |
Countries
Thailand
Contacts
Public ContactPeera Chaisirikul
Faculty of Medicine Siriraj Hospital
Outcome results
None listed