Efficacy of Adjunctive Deep Transcranial Magnetic Stimulation in Mania and relation with Lactate/Creatinine ratio in Anterior Cingulate Cortex: a sham controlled 1H-MRS study

Not Applicable

• Conditions: Health Condition 1: F312- Bipolar disorder, current episodemanic severe with psychotic featuresHealth Condition 2: F311- Bipolar disorder, current episodemanic without psychotic featuresHealth Condition 3: F301- Manic episode without psychotic symptomsHealth Condition 4: F302- Manic episode, severe with psychotic symptoms

• Registration Number: CTRI/2023/08/056673
• Lead Sponsor: Central Institute of Psychiatry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients fulfilling diagnosis of Bipolar type I disorder, current episode manic, with or

without psychotic symptoms (6A60.0, 6A60.1) according to International

Classification of Diseases 11th version (ICD-11)-Diagnostic Criteria for Research

(DCR) by World Health Organization (WHO, 2022)

2.Either sex 18-60 years

3.Patients amenable to follow instructions

4.Right-handed normotensive patients

5.Patients giving written informed consent

Exclusion Criteria

1.Patients having BP > 140/90 mmHg

2.Diagnosis of any other psychiatric disorder, mental retardation, history of substantial

brain damage, or any neurological or physical disorders

3.Patient with any substance dependence (except nicotine and caffeine)

4.Bipolar ?? disorder as according to International Classification of Diseases 11th version

(ICD-11)-Diagnostic Criteria for Research (DCR) by World Health Organization

(WHO, 2022)

5.Patients having any metallic implants/parts in body

6.Patients who had prior exposure to any mode of brain stimulation in last 6 months

7.Patient not giving informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess efficacy of adjunctive active dTMS in <br/ ><br>improving symptoms of mania as assessed on YMRS, BPRS & CGI.Timepoint: at baseline, before first <br/ ><br>session & after tenth session of adjunctive dTMS between manic patients receiving <br/ ><br>active & sham treatment

Secondary Outcome Measures

Name	Time	Method
To find out the relationship of Lactate/creatinine <br/ ><br>ratio in Anterior Cingulate Cortex on 1H-MRS with efficacy of adjunctive active dTMS in <br/ ><br>mania.Timepoint: at baseline, before first <br/ ><br>session & after tenth session of adjunctive dTMS between manic patients receiving <br/ ><br>active and sham treatment