MedPath

nderstanding unipolar and bipolar depression using magnetic stimulation of Brai

Not Applicable
Conditions
Health Condition 1: F30-F39- Mood [affective] disorders
Registration Number
CTRI/2022/09/045936
Lead Sponsor
ational Institute of Mental Health and Neurosciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Patients with Unipolar Depression

1.Written informed consent prior to any study specific procedures

2.A diagnosis of Major Depressive Disorder as per Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V)

3.HAMD score � 18

4.Males and females aged 18 to 45 years

5. Able to understand and comply with the requirements of the study

Patients with Bipolar Depression

1.Written informed consent prior to any study specific procedures

2.A diagnosis of Bipolar Disorder as per Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V)

3.Current episode being depressive episode with HAMD score � 18 and Absence of hypo/manic symptoms, defined as a YMRS score � 8 in past 2 months.

4.Males and females aged 18 to 45 years.

5.Able to understand and comply with the requirements of the study

Healthy Subjects

1.Written informed consent prior to any study specific procedures

2.No current or past diagnosis of psychiatric illness in the subject nor his/her first degree relatives, confirmed by clinical interview.

3.Males and females aged 18 to 45 years

4.Able to understand and comply with the requirements of the study

Exclusion Criteria

Patients with Unipolar Depression

1.Any DSM-V Axis I disorder not defined in the inclusion criteria

2.Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others

3.Administration of drugs that affect the brain GABA levels like Baclofen, Benzodiazepines, Antiepileptic drugs like valproate, tiagabine, etc.

4.Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-V criteria. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-V criteria within 4 weeks prior to enrolment

5.Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension or clinically relevant abnormal laboratory values) as judged by the investigator

Patients with Bipolar Depression

1.Any DSM-V Axis I disorder not defined in the inclusion criteria

2.Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others

3.Administration of drugs that affect the brain GABA levels like Baclofen, Benzodiazepines, Antiepileptic drugs like valproate, tiagabine, etc.

4.Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-V criteria. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-V criteria within 4 weeks prior to enrolment

Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension or clinically relevant abnormal laboratory values) as judged by the investigator

Healthy Subjects

1.Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension or clinically relevant abnormal laboratory values) as judged by the investigator

2.Involvement in the planning and conduct of the study

3.Participation in a drug trial within 4 weeks prior enrolment into this study or longer

Exclusion criteria for both patients and healthy controls:

Contraindications to TMS: Intracranial metal implants; cardiac pacemakers and other electronic implants; increased intracranial pressure or significant heart disease resulting from trauma or large infarctions, due to increased seizure risk; medication which reduces the seizure threshold, such as TCAs; immediate-family history, or with known, untreated epilepsy

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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