Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression

May 18, 2024 updated by: Mansoura University
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Warda F. Aboelez
  • Phone Number: 01018186408

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Mansoura University
        • Contact:
          • Warda F. Aboelez
          • Phone Number: 01018186408
        • Contact:
        • Principal Investigator:
          • Shaimaa E. Mohamed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with unipolar depression
Participants with Unipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks
Device: Transmagnetic stimulation
Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil
Device: TMS
Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil
Experimental: Participants with bipolar depression
Participants with bipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks
Device: Transmagnetic stimulation
Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil
Device: TMS
Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of severity of manic symptoms before and after treatment
Time Frame: One year for completion of the study
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.
Time Frame: One year for completion of the study
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
Time Frame: One year for completion of the study
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
Time Frame: One year for completion of the study
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: Hala A. El-boraie, Professor
  • Study Director: Ibrahim H. Rashed, Assistant Professor
  • Study Director: Hassan M. Sonbol, Lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

May 18, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 18, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD.22.12.731

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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