## Protocol Section
### Identification Module
**NCT ID:** NCT06422559

**Brief Title:** Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression

**Official Title:** Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression

#### Organization Study ID Info
**ID:** MD.22.12.731
#### Organization
**Class:** OTHER
**Full Name:** Mansoura University
### Status Module
#### Completion Date
**Date:** 2025-01-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-18

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-23
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mansoura University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** True

### Description Module

**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

### Conditions Module

**Conditions:**

- Depressive Disorder

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants with Unipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks

**Intervention Names:**

- Device: Transmagnetic stimulation

- Device: TMS

**Label:** Participants with unipolar depression

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants with bipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks

**Intervention Names:**

- Device: Transmagnetic stimulation

- Device: TMS

**Label:** Participants with bipolar depression

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Participants with bipolar depression

- Participants with unipolar depression

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

**Name:** Transmagnetic stimulation

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Participants with bipolar depression

- Participants with unipolar depression

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

**Name:** TMS

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Comparison of severity of manic symptoms before and after treatment

**Time Frame:** One year for completion of the study

**Description:** 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

**Measure:** 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

**Description:** 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)

**Measure:** Comparison of severity and impact of insomnia before and after treatment

**Time Frame:** One year for completion of the study

**Description:** 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)

**Measure:** Comparison of depressive symptoms before and after treatment

**Time Frame:** One year for completion of the study

### Eligibility Module

**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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** shaimaa_eldesokey151990@yahoo.com

**Name:** Shaimaa E. Mohamed

**Phone:** Egypt 01014947026

**Role:** CONTACT

**Contact 2:**

**Name:** Warda F. Aboelez

**Phone:** 01018186408

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Mansoura

**Contacts:**

***Contact 1:***

- **Email:** IRB.MFM@hotmail.com

- **Name:** Institutional R. Board

- **Phone:** Egypt +2050-2202773:2202746

- **Role:** CONTACT

***Contact 2:***

- **Name:** Warda F. Aboelez

- **Phone:** 01018186408

- **Role:** CONTACT

***Contact 3:***

- **Name:** Shaimaa E. Mohamed

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Egypt

**Facility:** Mansoura University

**Zip:** 35516

#### Overall Officials

**Official 1:**

**Affiliation:** Professor

**Name:** Hala A. El-boraie

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Assistant professor

**Name:** Ibrahim H. Rashed

**Role:** STUDY_DIRECTOR

**Official 3:**

**Affiliation:** Lecturer

**Name:** Hassan M. Sonbol

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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.

**PMID:** 33224435

#### See Also Links

**Label:** PMC 7675193

**URL:** https://pubmed.ncbi.nlm.nih.gov/33224435/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000068105

- Term: Bipolar and Related Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depressive Disorder

- ID: M4996

- Name: Bipolar Disorder

- Relevance: HIGH

- As Found: Bipolar Depression

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M226

- Name: Bipolar and Related Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003866

- Term: Depressive Disorder

- ID: D000001714

- Term: Bipolar Disorder

### Misc Info Module

- Version Holder: 2024-05-31
