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Clinical Trials/NCT06422559
NCT06422559
Not Yet Recruiting
N/A

Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression

Mansoura University1 site in 1 country60 target enrollmentJune 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depressive Disorder
Sponsor
Mansoura University
Enrollment
60
Locations
1
Primary Endpoint
Comparison of severity of manic symptoms before and after treatment
Status
Not Yet Recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
January 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

Study Sites (1)

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