Biomarkers in Depressed Inpatients Receiving Accelerated rTMS

NCT03628573 | Withdrawn

• 1 other identifier: H14-03368
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Repetitive transcranial magnetic stimulation (rTMS) is an emerging treatment for medically refractory major depressive disorder (MDD), and involves direct stimulation of cortical neurons using externally applied, powerful, focused magnetic field pulses. rTMS consistently achieves response rates of 50-55% and remission rates of 30-35% in medically refractory MDD patients. However, the vast majority of studies have focused its use in outpatient samples. This study will address whether accelerated rTMS (intermittent Theta Burst Stimulation (iTBS)) can speed up the response rate and shorten length of stay in hospital for inpatients, and which biological traits may predict response.

Conditions

Depression

Keywords

rTMS; Depression; Theta Burst Stimulation; Inpatients; Biomarkers

Outcome Measures

Primary Outcomes (3)

• To measure changes in EEG power, before and after 3 weeks of treatment with Theta Burst Stimulation in inpatients with depression.

  At baseline, 14 days, 2 weeks post-treatment

• To measure changes in cerebral blood flow before and after 3 weeks of treatment with Theta Burst Stimulation in inpatients with depression.

  At baseline, 14 days, 2 weeks post-treatment

• To measure changes in inflammatory markers before and after 3 weeks of treatment with Theta Burst Stimulation in inpatients with depression.

  At baseline, 2 weeks post-treatment

Secondary Outcomes (1)

• Change in depression score measured by MADRS over the course of Theta Burst Stimulation to accelerated rTMS in MDD in inpatient setting.

  At baseline, 5 days, 12 days, 20 days, 2 weeks post-treatment

Study Arms (1)

Intermittent Theta burst stimulation.

OTHER

Procedure: repetitive transcranial magnetic stimulation (iTBS) to the left Dorsolateral Prefrontal Cortex; 3 sessions per day, for 20 days.

Device: repetitive transcranial magnetic stimulation (MagPro X100).; Device: Intermittent Theta burst stimulation ( iTBS)

Interventions

repetitive transcranial magnetic stimulation (MagPro X100). DEVICE

accelerated rTMS.

Intermittent Theta burst stimulation.

Intermittent Theta burst stimulation ( iTBS) DEVICE

Intermittent Theta burst stimulation.

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are inpatients at the time of enrolment;
• are capable to consent to treatment;
• are experiencing a major depressive episode that is deemed as the principal concern during the current admission; (3.1) Those who are experiencing a bipolar depressive episode, are on a mood stabilizer;
• are between the ages of 19 and 65 years;
• have a score \>= 18 on the HDRS-17 item within 2-days prior to initiating TBS;
• have had no increase or initiation of antidepressant medication in the 4 weeks prior to initiation of TMS (according to clinical judgment);
• able to adhere to the treatment schedule;
• pass the TMS adult safety screening (TASS) questionnaire.

You may not qualify if:

• have a history of substance dependence or abuse within the last 3 months;
• have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump;
• have active suicidal intent;
• are experiencing psychosis;
• are pregnant;
• have failed a course of electroconvulsive therapy in the current depressive episode or previous episode;
• have received rTMS for any previous indication due to the potential compromise of expectancy effects;
• have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, history of epilepsy, cerebral aneurysm, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than 5 minutes;
• have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
• have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
• are currently (or in the last 4 weeks) taking lorazepam greater than 4 mg daily (or equivalent) or currently taking any dose of an anticonvulsant (those with unipolar depression).
• Note: those with Bipolar depression are allowed to be on mood stabilizers.
• have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

Sponsors & Collaborators

• University of British Columbia: lead

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Fidel Vila-Rodriguez, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Fidel Vila-Rodriguez

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: August 14, 2018
• Study Start: January 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: December 1, 2020

Record last verified: 2020-11