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Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression

M

Mansoura University

Status

Not yet enrolling

Conditions

Depressive Disorder

Treatments

Device: TMS
Device: Transmagnetic stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06422559
MD.22.12.731

Details and patient eligibility

About

The goal of this interventional study is to learn if accelerated Intermittent Theta Burst Stimulation can improve symptoms of 30 participants with Unipolar depression in higher manner than symptoms of 30 participants with bipolar depression

Full description

We will apply stimulatory TMS protocol for participants with Unipolar depression and participants with bipolar depression using MagVenture MagPro R30 stimulator with the Cool-B65 coil

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age:18_65 years
  • Sex:male and female
  • Patients with Unipolar depression and bipolar depression diagnosis confirmed by SCID according to DSM5
  • No pharmacological change in the last 4 weeks before the beginning of the stimulantion cycle
  • Pharmacological resistance

Exclusion criteria

  • Patients complaining of psychosis.Substance Use Disorder.current suicidal ideation.major medical and neurological disorder
  • Patients complaining of epilepsy
  • pregnancy and breastfeeding
  • peacemaker spinal or bladder stimulator
  • History of skull surgery and trauma
  • presence of metallic foreign body

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Participants with unipolar depression
Experimental group
Description:
Participants with Unipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks
Treatment:
Device: TMS
Device: Transmagnetic stimulation
Participants with bipolar depression
Experimental group
Description:
Participants with bipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks
Treatment:
Device: TMS
Device: Transmagnetic stimulation

Trial contacts and locations

1

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Central trial contact

Shaimaa E. Mohamed; Warda F. Aboelez

Data sourced from clinicaltrials.gov

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