Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression

Not Applicable

Not yet recruiting

• Conditions: Depressive Disorder
• Interventions: Device: Transmagnetic stimulation; Device: TMS

• Registration Number: NCT06422559
• Lead Sponsor: Mansoura University

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

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 Timeline

• Study First Submitted: 2024-04-23
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-18
• Last Update Submitted: 2024-05-18
• Study First Posted: 2024-05-21
• Last Update Posted: 2024-05-21
• Study Start: 2024-06-01
• Primary Completion: 2024-12-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants with bipolar depression	Transmagnetic stimulation	Participants with bipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks
Participants with bipolar depression	TMS	Participants with bipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks
Participants with unipolar depression	Transmagnetic stimulation	Participants with Unipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks
Participants with unipolar depression	TMS	Participants with Unipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks

Primary Outcome Measures

Name	Time	Method
Comparison of severity of manic symptoms before and after treatment	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.	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	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	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)

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt