| CTRI Number |
CTRI/2023/09/057824 [Registered on: 18/09/2023] Trial Registered Prospectively |
| Last Modified On: |
11/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of medication response in individuals having depressive disorder using blood test and brain activity and comparing them to healthy individuals |
|
Scientific Title of Study
|
A longitudinal observational study to evaluate antidepressant medication response using brain derived nerve growth factor and cortical hemodynamic and electrical activity |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ahmad Najjad Husain |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Psychiatry
AIIMS New Delhi
Ansari Nagar east
South West DELHI 110029 India |
| Phone |
9447941574 |
| Fax |
|
| Email |
anajjadpatla@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rohit Verma |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Psychiatry, Room no. 4095 4th floor, Teaching block AIIMS, Ansari Nagar, New Delhi
South West DELHI 110029 India |
| Phone |
9868005491 |
| Fax |
|
| Email |
rohit.aiims@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Rohit Verma |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Psychiatry, Room no. 4095 4th floor, Teaching block AIIMS, Ansari Nagar, New Delhi
South West DELHI 110029 India |
| Phone |
9868005491 |
| Fax |
|
| Email |
rohit.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
|
All India Institute of Medical Science, New Delhi, India |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Department of Psychiatry
AIIMS New Delhi
Ansari Nagar east 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ahmad Najjad Husain |
All India Institute of Medical Science New Delhi |
Room No. 4096, 4th Floor, Teaching Block Department of Psychiatry, AIIMS, Ansari Nagar
New Delhi South West DELHI |
9447941574
anajjadpatla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee for postgraduate research, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not suffering from any psychiatric illness on clinical evaluation |
| Patients |
(1) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
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) |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in HAMD scores & cortical activity within patient group & comparison of cortical activity between patient group & healthy group |
at baseline & after 4 & 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BDNF gene polymorphism correlation with depression severity |
baseline |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Worldwide, there is
high prevalence of depressive disorder. Pharmacological treatment strategies to
manage depression are limited by effectiveness as well as tolerability issues
apart from the late onset of action. Extent of antidepressant
medication response often differs with individual variation and surrogate markers
predicting non-response at the earliest possible time are needed to avoid
leaving patients under an inefficient medication/ treatment. The use of brain imaging techniques like
fNIRS/qEEG can depict the cortical activity associated with the changes in
symptoms of depression. Literature has reported lower levels of BDNF in
depression that improves with response to treatment. BDNF Val66Met polymorphism may help in
predicting treatment responders. The study hypothesizes that individuals with MDD differ from healthy individuals
for prefrontal hemodynamic activity assessed using fNIRS and cortical
electrical activity assessed using qEEG and that individuals with MDD after treatment with
antidepressant medications demonstrate changes in depressive symptoms,
Prefrontal hemodynamic activity assessed using fNIRS, cortical electrical
activity assessed using qEEG and serum BDNF levels. The study also hypothesizes that the presence of Val66Met BDNF gene polymorphism is
associated with change in depressive symptoms after antidepressant treatment in
individuals with MDD. Consultants and Senior Residents in the outpatient
department (OPD) and inpatient department (IPD) of Psychiatry, AIIMS, New Delhi shall be requested to refer all the patients
with depression. Out of the referred patients, those with
HAMD score >17 (moderate
depression) will be chosen by a purposive method for participation in the study. Diagnosis of severe depression will be confirmed
using DSM-5 criteria
by clinical interview and participants fulfilling the inclusion and exclusion criteria
will be recruited. Participants
will be screened for psychiatric
comorbidities using clinical interview. Physical, neurological and substance use comorbidity as well as
pregnancy/lactation will be ruled out by history and clinical examination. Written
consent will be taken prior to
participation in the study.
Healthy controls will also be recruited similarly from the outpatient
department (OPD) and inpatient department (IPD) of Psychiatry, AIIMS, New Delhi, who are meeting inclusion and
exclusion criteria.
For both the groups baseline assessment will be done
within 2 days of assessments by sociodemographic and clinical data using semi
structured datasheet and outcome parameters by fNIRS and qEEG for both the
group. 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. |