A longitudinal observational study to evaluate antidepressant medication response using brain derived nerve growth factor and cortical hemodynamic and electrical activity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in HAMD scores & cortical activity within patient group & comparison of cortical activity between patient group & healthy group
研究概览
简要总结
Worldwide, there ishigh prevalence of depressive disorder. Pharmacological treatment strategies tomanage depression are limited by effectiveness as well as tolerability issuesapart from the late onset of action. Extent of antidepressantmedication response often differs with individual variation and surrogate markerspredicting non-response at the earliest possible time are needed to avoidleaving patients under an inefficient medication/ treatment. The use of brain imaging techniques likefNIRS/qEEG can depict the cortical activity associated with the changes insymptoms of depression. Literature has reported lower levels of BDNF indepression that improves with response to treatment. BDNF Val66Met polymorphism may help inpredicting treatment responders.
The study hypothesizes that individuals with MDD differ from healthy individualsfor prefrontal hemodynamic activity assessed using fNIRS and corticalelectrical activity assessed using qEEG and that individuals with MDD after treatment withantidepressant medications demonstrate changes in depressive symptoms,Prefrontal hemodynamic activity assessed using fNIRS, cortical electricalactivity assessed using qEEG and serum BDNF levels. The study also hypothesizes that the presence of Val66Met BDNF gene polymorphism isassociated with change in depressive symptoms after antidepressant treatment inindividuals with MDD.
Consultants and Senior Residents in the outpatientdepartment (OPD) and inpatient department (IPD) of Psychiatry, AIIMS, New Delhi shall be requested to refer all the patientswith depression. Out of the referred patients, those withHAMD score >17 (moderatedepression) will be chosen by a purposive method for participation in the study. Diagnosis of severe depression will be confirmedusing DSM-5 criteriaby clinical interview and participants fulfilling the inclusion and exclusion criteriawill be recruited. Participantswill be screened for psychiatriccomorbidities using clinical interview. Physical, neurological and substance use comorbidity as well aspregnancy/lactation will be ruled out by history and clinical examination. Writtenconsent will be taken prior toparticipation in the study.Healthy controls will also be recruited similarly from the outpatientdepartment (OPD) and inpatient department (IPD) of Psychiatry, AIIMS, New Delhi, who are meeting inclusion andexclusion criteria.
For both the groups baseline assessment will be donewithin 2 days of assessments by sociodemographic and clinical data using semistructured datasheet and outcome parameters by fNIRS and qEEG for both thegroup. For other outcome parameters will also be assessed namely HAMD, HAMA,BDNF and BDNF gene polymorphism.
Only the MDD group will be reassessed at 4 and 8 weeks(±2-3 days) using HAMD, HAMA, BDNF level, fNIRS, qEEG.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
入选标准
- •Inclusion criteria – MDD group 1.Age 18 to 55 years 2.Any gender 3.Right-handed subjects 4.Willing to give written informed consent 5.Ability to read Hindi or English language 6.Meeting DSM 5 criteria for Major Depressive Disorder (MDD) 7.Treatment naïve or Treatment free from prior 2 weeks or on a stable standard antidepressant regimen with no change in treatment in previous 4-weeks.
- •8.Prescribed antidepressants for treatment of MDD on the day of screening/recruitment 9.HAMD score ≥ 17 (moderate to severe depression) (Zimmerman et al., 2013) Inclusion criteria – Healthy controls 1.Age (18 to 55 years) matched (± 5 years) and Gender matched 2.Right-handed 3.Willing to give written informed consent 4.Ability to read Hindi or English language 5.Not suffering from any psychiatric illness (on clinical evaluation).
排除标准
- •1.Suffering from any psychotic symptoms or other psychiatric disorder or substance use disorder (except caffeine & nicotine) through clinical interview using DSM 5 2.Persistent Depressive Disorder (dysthymia), Premenstrual Dysphoric Disorder, Depressive Disorder Due to Another Medical Condition, Substance/ Medication Induced Depressive Disorder, Other and Unspecified Depressive Disorders based on DSM 5 3.History of seizures 4.Pregnancy/ Lactation 5.Uncontrolled medical illness 6.History suggestive of space occupying brain lesion or cerebrovascular accident 7.Current prescription or history within last 3-months of receiving any Psychotherapy/Neuromodulation 8.Actively suicidal as defined by a score of 4 on item 3 of HAMD.
结局指标
主要结局
Change in HAMD scores & cortical activity within patient group & comparison of cortical activity between patient group & healthy group
时间窗: at baseline & after 4 & 8 weeks
次要结局
- BDNF gene polymorphism correlation with depression severity(baseline)