Magnetic Seizure Therapy in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD)

Part of paid clinical trials in Houston, Texas.

Sponsor
Joao L. DeQuevedo
Study ID
NCT04080778
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • magnetic seizure therapy (MST) — DEVICE
    MST will be performed with the MagPro XP (120 V) device under anesthesia 2-3 times a week up to 15 sessions.Treatment is performed by magnetic stimulation of both hemispheres inducing a focal stimulation above vertex, using a serial of pulse trains with a frequency of at least 25 Hz but up to 100 Hz for 4-6 s (up to 10 s), which is sufficient to induce a tonic clonic seizure.
  • electroconvulsive therapy (ECT) — DEVICE
    ECT will be performed with MECTA 5000Q, 4th generation ECT devices provided by MECTA Corporation under anesthesia 2-3 times a week up to 15 sessions. For initial procedure Seizure Threshold (ST) will be estimated by empiric titration in the first session of each participant. ST will be then determined as by the manufacturer of ECT Device by the titration schedule for the initial titration session. The subsequent treatment sessions were dosed at 6 times the charge of the seizure threshold.

Study Details

The purpose of this study is to compare the efficacy and side effects magnetic seizure therapy (MST) and electroconvulsive therapy (ECT) in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD).

Key Dates

Start date
Aug 24, 2024
Status verified
Nov 2025
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: magnetic seizure therapy (MST)
  • Active Comparator: electroconvulsive therapy (ECT)

Primary Outcome Measure

Number of participants who go into remission [ Time Frame: From baseline to week 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Joao L. De Quevedo, MD,PhD
[email protected]
713-486-2705
Ana Ruiz
[email protected]
(713) 741-3951

Find similar trials in Houston, TX

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
The University of Texas Health Science Center at Houston· Houston, TX

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