Evaluation of Safety and Efficacy of tDCS in Conjunction with Pharmacotherapy for Mild to Moderate General Anxiety Disorder (GAD): A Double-Blind, Randomized, Placebo-Controlled Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Establishing the Safety profile of Transcranial Direct Current Stimulation in Generalized Anxiety Disorder.
Study Overview
Brief Summary
This study evaluates the safety and efficacy of a transcranial direct current stimulation (tDCS) device in conjunction with pharmacotherapy for individuals with mild to moderate Generalized Anxiety Disorder (GAD). Conducted as a double-blind, randomized, placebo-controlled trial at Raja Rajeswari Medical College and St. John’s Medical College in Bengaluru, India, the study will enroll approximately 90 participants aged 18–60 years meeting DSM-5-TR criteria for GAD. Participants will be randomly assigned to receive either an active tDCS device or a non-functional placebo device for 20-minute sessions, five days a week, over three weeks, while continuing prescribed pharmacotherapy. The study will assess improvements in anxiety symptoms and executive function using tools like the Hamilton Anxiety Rating Scale (HAM-A), cognitive tasks (Trail Making Part B, Mackworth Clock Test), and Visual Analog Scales. Safety will be monitored through adverse event reporting. Exclusion criteria include severe comorbid medical or psychiatric conditions, substance use disorders, and pregnancy. Data will be analyzed using R software to establish the efficacy and safety of tDCS as an adjunct therapy for GAD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adults, 18 to 60 years of age at the time of screening of either gender (male and female).
- •Hamilton Anxiety Rating Scale (HAM-A) score ≥ 15 (Final threshold to be determined based on study focus on moderate to severe cases)
- •Subjects must meet all the following criteria for GAD as defined by DSM-5-TR: Excessive anxiety and worry occurring for more days, but not more than 6 months.
- •Difficulty controlling worry ≥ 3 of the following symptoms: Restlessness or feeling keyed up or on edge Being easily fatigued Difficulty concentrating or mind going blank Irritability Muscle tension Sleep disturbance Symptoms cause clinically significant distress or impairment.
- •Diagnosis confirmed by licensed mental health professional
- •No change in the dosage of Psychiatric medication for ≥ 4 weeks prior to enrolment
- •No change in the Psychotherapy ≥ 4 weeks prior to enrolment.
- •There should be no change in Psychiatric medication of the subject during the complete trial period.
- •No planned medication changes during the study period
- •Subjects with ability to sign informed consent form
- •Demonstrated understanding of study nature, risks and benefits
- •Fluent in consent language
- •Willing to comply with all study procedures and follow-up.
Exclusion Criteria
- •Subject who participated in other study within the past 3 months.
- •Patients with a history of head trauma.
- •Moderate to severe traumatic brain injury (TBI).
- •Head injury requiring hospitalization.
- •Loss of consciousness for more than 30 minutes in past 3 months.
- •Post-concussive syndrome within past 2 years.
- •Patients with presence of metal implants in or around the head such as Cochlear implants, aneurysm clips, brain stimulators, skull plates, deep brain stimulators, shrapnel or bullet fragments, external hearing aids, any other implants in the opinion of PI hat could interfere with tDCS.
- •Patients with any history of neurological surgery such as brain surgery, neurological procedures involving skull, intracranial or cervical spine surgery, deep brain stimulation procedures.
- •Medical conditions including, cardiovascular disease (heart attacks, artery/valve related issues, arrhythmia etc.), thyroid dysfunction, active autoimmune conditions (systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disorder etc.), chronic pain requiring opioid medication.
- •Patients with history of seizure or epilepsy, on current anticonvulsant medication use.
- •Patients with suicidal tendency such as, suicide attempt, current suicidal ideation, C-SSRS and MADRS score indicating any risk, history of multiple suicide attempts.
- •Uncorrected hearing/visual impairment affecting participation as per PI opinion.
- •Comorbid conditions which are schizophrenia or psychotic disorder, bipolar disorder (Type I or II), current major depressive episode, interfering personality disorders, psychiatric hospitalization within 6 months, somatoform or dissociate disorders, eating disorders, narcolepsy.
- •Substance use disorder within past 12 months, active substance use (excluding nicotine, caffeine), and alcohol consumption more than 14 units/week within the past week.
- •Subjects undergoing chemotherapy, or with a history of chemotherapy or cancer.
- •Pregnant, breastfeeding/lactating, or planning pregnancy during the study period.
- •If a patient is already enrolled in a clinical trial
- •Any medical condition apart from those mentioned above which in the opinion of PI would affect the study participation.
Outcomes
Primary Outcomes
Establishing the Safety profile of Transcranial Direct Current Stimulation in Generalized Anxiety Disorder.
Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, and 4 weeks
Reduction in anxiety symptoms, as measured by the provided scales (HAM-A, HDRS, PSQI, K-10, C-SSRS, MADRS and VAS) in the individuals with mild and moderate GAD following the use of the tDCS device.
Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, and 4 weeks
Secondary Outcomes
- Improvement in executive function, measured using validated neuropsychological assessments (Trail Making Part B, Mackworth Clock Test, Sternberg Task, Stop Signal Paradigm), in individuals with mild & moderate GAD after the intervention with the tDCS device.(Baseline, 1 week, 2 weeks, 3 weeks, & 4 weeks)
Investigators
Dr Johnson Pradeep R
St. Johns Medical College Hospital