Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression

NCT06422559 | Not Yet Recruiting

• 1 other identifier: MD.22.12.731
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (4)

• Comparison of severity of manic symptoms before and after treatment

  We will use Young Mania Rating Scale.\_Young Mania Rating Scale:assess severity of manic symptoms, clinician rated,\<=12(remission)13\_19(minimal symptoms)20\_25(mild mania)26\_37(moderate mania)38\_60 severe mania

  One year for completion of the study

• Comparison of the severity of the patient's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis.

  We will use Clinical Global Impression Severity Scale.\_Clinical Global Impression Severity Scale:rate the severity of the patient's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis,1 normal not at all ill,2 borderline mentally ill,3 mildly ill,4 moderately ill,5 markedly ill,6 severely ill,7 extremely ill

  One year for completion of the study

• Comparison of severity and impact of insomnia before and after treatment

  We will use Insomnia Severity Index scale.\_Insomnia Severity Index:assess the nature, severity and impact of insomnia,0\_7(absence insomnia) 8\_14(subthreshold insomnia)15\_21(moderate insomnia)22\_28(severe insomnia)

  One year for completion of the study

• Comparison of depressive symptoms before and after treatment

  We will use Hamilton Depression Rating Scale.\_Hamilton Depression Rating Scale:assess the severity of depressive symptoms, clinician rated,0\_7(normal range)8\_16(mild severity)17\_23(moderate severity)\>23(severe depression)

  One year for completion of the study

Study Arms (2)

Participants with unipolar depression

EXPERIMENTAL

Participants with Unipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks

Device: Transmagnetic stimulation; Device: TMS

Participants with bipolar depression

EXPERIMENTAL

Participants with bipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks

Device: Transmagnetic stimulation; Device: TMS

Interventions

Transmagnetic stimulation DEVICE

Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil

Participants with bipolar depression; Participants with unipolar depression

TMS DEVICE

Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil

Participants with bipolar depression; Participants with unipolar depression

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

Related Publications (1)

• Chang J, Chu Y, Ren Y, Li C, Wang Y, Chu XP. Maintenance treatment of transcranial magnetic stimulation (TMS) for treatment-resistant depression patients responding to acute TMS treatment. Int J Physiol Pathophysiol Pharmacol. 2020 Oct 15;12(5):128-133. eCollection 2020.

  PMID: 33224435 BACKGROUND

Related Links

• PMC 7675193

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Hala A. El-boraie

  Professor

  STUDY CHAIR

• Ibrahim H. Rashed

  Assistant professor

  STUDY DIRECTOR

• Hassan M. Sonbol

  Lecturer

  STUDY DIRECTOR

Central Study Contacts

Shaimaa E. Mohamed

CONTACT

Egypt 01014947026; shaimaa_eldesokey151990@yahoo.com

Warda F. Aboelez

CONTACT

01018186408

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 21, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)