Comparison of Anodal Transcranial Direct Current Stimulation (t-DCS) and Sham Stimulation in Patients With Treatment-resistant Depression

NCT02141776 | Completed Phase 4 DMC

• 2 other identifiers: 95-2013IRB201501014
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Major depressive disorder (MDD) is a significant public health problem. Existing treatment modalities are not always sufficient to alleviate this disorder. Treatment refractoriness is a common clinical problem. Transcranial direct current stimulation (t-DCS), a non-invasive brain stimulation technique, has been shown to be effective in alleviating depressive symptoms in preliminary studies. There is need to explore the role of t-DCS in Treatment-resistant depression (TRD). Therefore, the investigators aim to undertake this exploratory study. Aim: Compare the role of left prefrontal cortex anodal t-DCS daily stimulation of 4 weeks (20 week days) with sham stimulation in alleviating depressive symptoms in patients with TRD. Methodology: Patients who seek treatment in our treatment resistant depression clinic and who have failed to respond to treatment with two antidepressant medications will be offered to enroll in this study. The aim is to study 20 patients who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for MDD between the ages of 21-65 years. Those subjects that receive sham stimulation will be offered to have active t-DCS stimulation for additional 3 weeks to get any benefit that they may have otherwise missed by being in the sham stimulation group. Results and Conclusions: The investigators will compare the mean baseline and end of treatment Montgomery Asberg depression rating scale between the two groups. The investigators will compare the change in mean depression scores between the baseline and end of treatment in those receiving active t-DCS for a total of 7 weeks duration. This study is innovative and of significance in exploring the role of this novel, easy to administer, safe and cost effective treatment modality.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg depression rating scale score

  Investigators will measure the changes in Montgomery Asberg depression rating scale scores with trans-cranial direct current stimulation

  6 months

Study Arms (2)

Sham Controlled Arm

SHAM COMPARATOR

The subjects randomized to this group will not receive stimulation daily for four weeks.

Other: Sham Controlled Arm

Transcranial direct current stimulation (t-DCS)

ACTIVE COMPARATOR

The subjects randomized to this group will receive anodal t-DCS stimulation daily for four weeks. The stimulation parameters: current 2 mA continuously for 30 minutes.

Device: Transcranial direct current stimulation (t-DCS)

Interventions

Transcranial direct current stimulation (t-DCS) DEVICE

The subjects randomized to this group will receive anodal t-DCS stimulation daily for four weeks. The stimulation parameters: current 2 mA continuously for 30 minutes.

Transcranial direct current stimulation (t-DCS)

Sham Controlled Arm OTHER

The subjects randomized to this group will not receive stimulation daily for four weeks.

Sham Controlled Arm

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects that meet criteria for Major depressive disorder (MDD)
• ages 21 to 65 years and
• who are treatment resistant

You may not qualify if:

• Co-morbid substance abuse in last one month.
• Psychotropic medication changes in last two weeks.
• Unstable medical or psychiatric problems that need intensive outpatient or inpatient treatment
• Patients who are not competent to consent for the study
• Urine pregnancy test positive
• Ferromagnetic Implanted devices that use electrical or magnetic currents

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Univ of Florida

Gainesville, Florida, 32606, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Khurshid Khurshid, M.D

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 19, 2014
• Study Start: May 1, 2014
• Primary Completion: January 8, 2018
• Study Completion: January 8, 2018
• Last Updated: January 12, 2018

Record last verified: 2018-01

Locations

US (1)