Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression

Depressive Disorder Clinical Trial

Official title:

Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06422559
• Other study ID #: MD.22.12.731
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2024
• Source: Mansoura University
• Contact: Shaimaa E. Mohamed
• Phone: Egypt 01014947026
• Email: shaimaa_eldesokey151990[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder

Intervention

Device:
• Transmagnetic stimulation
Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil
• TMS
Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   PMC 7675193