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Efficacy of Theta Burst Transcranial Magnetic Stimulation in Bipolar Depression : A randomized Placebo Controlled Trial

Efficacy of Adjunctive Theta Burst Transcranial Magnetic Stimulation in Bipolar Depression -A Randomized Placebo Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/035182
Enrollment
40
Registered
2021-07-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F314- Bipolar disorder, current episodedepressed, severe, without psychotic features

Interventions

Intervention1: cTBS: cTBS treatment will be delivered over rDLPFC for 3 sessions for 5 days a week spaced 30 minutes apart.A stimulation intensity of 80 % of the motor threshold (MT) of the right abd

Sponsors

SGRRIMHS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Diagnosis of moderate to severe Bipolar disorder with current episode of Depression 2) Baseline HAM-D Score >18 3) Right Handed nor Mo tensive patient

Exclusion criteria

Exclusion criteria: 1) Neurological Disorder such as epilepsy,organic brain damage or any neurological procedure. 2) Pacemakers or other metal parts in the body 3) ECT in the past 6 months 4) Any comorbid Psychosis 5) History of non response to rTMS treatment 6) Alcohol or any other substance dependence except Nicotine and Caffine

Design outcomes

Primary

MeasureTime frame
To assess and compare the change in Depressive symptoms in Bipolar Depression among active and placebo groupTimepoint: Screening ,Baseline ,7th Day post initiation of therapy, 21st Day post initiation of therapy

Secondary

MeasureTime frame
To assess and compare change in anxiety symptoms in bipolar depressionTimepoint: Baseline ,7th Day post initiation of therapy, 21st Day post initiation of therapy;To assess and compare change in quality of life in bipolar depressionTimepoint: Baseline ,7th Day post initiation of therapy, 21st Day post initiation of therapy;To assess and compare change in sexual dysfunction in bipolar depressionTimepoint: Baseline ,7th Day post initiation of therapy, 21st Day post initiation of therapy

Countries

India

Contacts

Public ContactGunjan Malik

SGRRM&HS

shobit.garg@gmail.com8958534261

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026