CClinicalTrials.gg
Not yet recruitingNCT06422559Updated May 21, 2024

Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression

An interventional study of Transmagnetic stimulation and TMS in Depressive Disorder, sponsored by Mansoura University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-21.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Depressive Disorder
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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 · Device: TMS

  • 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 · Device: TMS

Interventions

  • DeviceTransmagnetic stimulation

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

  • DeviceTMS

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: One year for completion of the study

  2. 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

    Time frame: One year for completion of the study

  3. 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)

    Time frame: One year for completion of the study

  4. 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)

    Time frame: One year for completion of the study

07

Study locations

1 site
  • Mansoura University
    Mansoura, 35516, Egypt
    • Institutional R. Board · Contact · IRB.MFM@hotmail.com · Egypt +2050-2202773:2202746
    • Warda F. Aboelez · Contact · 01018186408
    • Shaimaa E. Mohamed · Principal investigator
08

References and documents

Publications

  • 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. PubMed 33224435 ↗

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06422559
Lead sponsor
Mansoura University
Responsible party
Sponsor
First posted
May 21, 2024
Start date
Jun 1, 2024 (estimated)
Primary completion
Dec 1, 2024 (estimated)
Completion
Jan 1, 2025 (estimated)
Last update
May 21, 2024

Study contacts

Shaimaa E. Mohamed
Contact
shaimaa_eldesokey151990@yahoo.com
Egypt 01014947026
Warda F. Aboelez
Contact
01018186408
Hala A. El-boraie
study chair · Professor
Ibrahim H. Rashed
study director · Assistant professor
Hassan M. Sonbol
study director · Lecturer

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion