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

Not yet recruiting

Conditions: Bipolar disorder, current episodedepressed, severe, without psychotic features,

Brief Summary: This study aims to investigate the clinical efficacy of continuous theta burst stimulation (cTBS) on the right DLPFC in bipolar depression. For this study Bipolar depressed patients will be selected by a certified psychiatrist. The presence of exclusion criteria will be evaluated. Eligible patients will undergo Baseline clinical assessments and research assessments. TBS involves applying triple-pulse 50 Hz bursts given at a rate of 5 Hz uninterrupted trains (1). Patients will be treated with in total 15 (3 sessions per day)continuous Theta Burst Stimulation (cTBS) session (200 pulses per session) over the right dorsolateral prefrontal cortex, which will be spread over 5 days a week. A stimulation intensity of 80% of the subjectâ€™s motor threshold (MT) of the right abductor pollicis brevis muscle will used. Patients will be randomized to receive either the real cTBS or sham treatment. Sham stimulation will be applied with a sham coil. The sham coil produces identical sounds but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS. Two post-treatment assessment will take place respectively 7 days and 21 days post initiation of treatment .

1. (1) Chung S, Hoy K , Fitzgerald P. Theta-burst stimulation: a new form of TMS treatment for depression. Depression and Anxiety *.*2014;32(3): 182-192.

Recruitment & Eligibility

Inclusion Criteria

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

1. Neurological Disorder such as epilepsy,organic brain damage or any neurological procedure.
1. 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.

Primary Outcome Measures

Name	Time	Method
To assess and compare the change in Depressive symptoms in Bipolar Depression among active and placebo group	Screening ,Baseline ,7th Day post initiation of therapy, 21st Day post initiation of therapy

Secondary Outcome Measures

Name	Time	Method
To assess and compare change in anxiety symptoms in bipolar depression	Baseline ,7th Day post initiation of therapy, 21st Day post initiation of therapy
To assess and compare change in quality of life in bipolar depression	Baseline ,7th Day post initiation of therapy, 21st Day post initiation of therapy
To assess and compare change in sexual dysfunction in bipolar depression	Baseline ,7th Day post initiation of therapy, 21st Day post initiation of therapy

Locations (1): SGRRIM&HS
🇮🇳
Dehradun, UTTARANCHAL, India
SGRRIM&HS
🇮🇳Dehradun, UTTARANCHAL, India
Dr Shobit Garg
Principal investigator
8958534261
shobit.garg@gmail.com