Depressive DisorderNCT06422559
Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression
A study testing Transmagnetic stimulation and TMS in people with Depressive Disorder, run by Mansoura University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Transmagnetic stimulation and TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Warda F. Aboelez contact
Egypt1 site
Mansoura University
Al Mansurah, 35516
Institutional R. Board, Egypt +2050-2202773:2202746, IRB.MFM@hotmail.com
Warda F. Aboelez, 01018186408
About this study
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
- Conditions
- Depressive Disorder
- Being tested
- Transmagnetic stimulation, TMS
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transmagnetic stimulationDevice
Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil
TMSDevice
Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil
| Study group | Role | What they receive |
|---|---|---|
| Participants with unipolar depression | Experimental | Participants with Unipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks Receives: 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 Receives: Device: Transmagnetic stimulation; Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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)
Measured: One year for completion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hala A. El-boraie, Study chair, ProfessorIbrahim H. Rashed, Study director, Assistant professorHassan M. Sonbol, Study director, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422559
- Sponsor's protocol ID
- MD.22.12.731
- Status last verified
- May 2024
- First submitted
- 23 Apr 2024
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression
- ClinicalTrials.gov ID
- NCT06422559
- Acronym / sponsor ID
- MD.22.12.731
- Conditions
- Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with unipolar depression | Experimental | Device: Transmagnetic stimulation, Device: TMSParticipants with Unipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks |
| Participants with bipolar depression | Experimental | Device: Transmagnetic stimulation, Device: TMSParticipants with bipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transmagnetic stimulationStimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil | Device | Participants with bipolar depression, Participants with unipolar depression |
| TMSStimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil | Device | Participants with bipolar depression, Participants with unipolar depression |
Primary outcome
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
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
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Background: PubMed 33224435Chang 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.
- PMC 7675193Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warda F. Aboelez contact
Hala A. El-boraie study chair
Professor
Ibrahim H. Rashed study director
Assistant professor
Hassan M. Sonbol study director
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transmagnetic stimulation and TMS in people with Depressive Disorder, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaimaa E. Mohamed (Egypt 01014947026, shaimaa_eldesokey151990@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of severity of manic symptoms before and after treatment (time frame: One year for completion of the study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06422559, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.