Health Condition 1: F30-F39- Mood [affective] disorders
Conditions
Interventions
None listed
Sponsors
National Institute of Mental Health and Neurosciences
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ To evaluate GABA mediated cortical inhibition, using single-pulse and paired-pulse TMS, in unipolar and bipolar depression as compared to healthy controls.Timepoint: The cortical inhibition parameters will be measured at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢To examine the differences between GABA-A and GABA-B markers of cortical inhibition in unipolar and bipolar depression compared to healthy controls ââ?¬Â¢To assess the correlation between the severity of depression, as measured by HAMD, with TMS measures of cortical inhibition Timepoint: The cortical inhibition parameters will be measured at baseline | — |
Countries
India
Contacts
Public ContactDr Rashmi A
NIMHANS, Bangalore
Outcome results
None listed