Safety and Efficacy of Synchronized Transcranial Magnetic Stimulation (sTMS) for the Treatment of Generalized Anxiety Disorder (GAD) -An Open Label Investigator Initiated Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Generalized Anxiety Disorder (GAD)
- Sponsor
- University of Texas Southwestern Medical Center
- Primary Endpoint
- Mean change in score on the Hamilton Anxiety Rating Scale (HAM-A)
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
This clinical trial is an investigator-initiated open label study designed to evaluate the safety and efficacy of sTMS in subjects with Generalized Anxiety Disorder.
Detailed Description
Subjects will receive 5 daily treatments per treatment week for 4 weeks (20 treatments). Patients who do not meet a 50% reduction of Hamilton Anxiety Rating Scale (HAM-A) score (non-responders) at 4 weeks will be offered 2 additional treatment weeks for up to 30 treatments total. Subjects who qualify for enrollment will be followed and assessed using the: Mini International Neuropsychiatric Interview (MINI) for Axis 1, Montreal Cognitive Assessment (MoCA), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D17), Generalized Anxiety Disorder 7-item (GAD-7), and Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR16) patient reported scale. Treatment will be initiated on Day 1 of the study and will be continued for a minimum of 4 and a maximum of 6 weeks.
Investigators
Mustafa Husain
Vice Chair, Department of Psychiatry, Professor of Psychiatry, Neurology & Medicine, Director, Neuromodulation Research & Therapeutics Program
University of Texas Southwestern Medical Center
Eligibility Criteria
Inclusion Criteria
- •All subjects will be 18 - 65 years of age.
- •Primary Diagnosis of Generalized Anxiety Disorder (GAD) confirmed by structured interview using the Mini International Neuropsychiatric Interview (MINI), version 7, with minimum duration of current episode of 3 months
- •Baseline Hamilton Anxiety (HAM-A) score equal or greater than 18
- •The baseline EEG is of sufficient duration and quality that it can be processed for quantitative analysis.
- •Taking less than or equal to 2 psychotropic medications at a stable dose for a minimum of 2 weeks to remain unchanged throughout duration of study.
- •Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits.
Exclusion Criteria
- •Subjects are unable or unwilling to give informed consent.
- •Primary Diagnosis with the following conditions confirmed by MINI (current unless otherwise stated):
- •GAD secondary to a general medical condition, or substance-induced.
- •History of substance abuse or dependence within the past 6 months (except nicotine and caffeine).
- •Major depressive disorder, bipolar disorder or psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes.
- •Eating disorder (current or within the past year).
- •Obsessive compulsive disorder (lifetime).
- •Post-traumatic stress disorder (current or within the past year).
- •Attention Deficit Hyperactivity Disorder (ADHD) currently being treated.
- •Subjects meeting criteria for Axis II cluster A or B diagnosis based upon Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria, which in the judgment of the Investigator may hinder the subjects in completing the procedures required by the study protocol.
Outcomes
Primary Outcomes
Mean change in score on the Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: Baseline to Week 4
Secondary Outcomes
- Clinical response on the Hamilton Anxiety Rating Scale(Baseline to Week 4)
- Clinical response on the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR16)(Baseline to Week 4)
- Clinical response on the Hamilton Depression Rating Scale (HAM-D17)(Baseline to Week 4)
- Clinical response on the Generalized Anxiety Disorder 7-item scale (GAD-7)(Baseline to Week 4)