nderstanding unipolar and bipolar depression using magnetic stimulation of Brai
- 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
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
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
Name Time Method
- Secondary Outcome Measures
Name Time Method