Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic features
Conditions
Interventions
Intervention1: Ketamine infusion: 6 session with infusion of ketamine hydrochloride (0.5mg/kg in 0.9% normal saline amounting to 40ml IV over 40min) in one session
Control Intervention1: Normal saline
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 to 55 years Any gender Right handed subjects Willing to give written informed consent Ability to read Hindi or English language Meeting DSM 5 criteria for Major Depressive Disorder Treatment naive or Treatment free from prior 2 weeks or on a stable standard antidepressant regimen, with no change in treatment in previous 4weeks. Prescribed antidepressants for treatment of MDD on the day of screening/recruitment HAMD score Actively suicidal as defined by HAMD score = 1 for item no. 3 (assessing suicidal ideation) Zimmerman et al 2013
Exclusion criteria
Exclusion criteria: Suffering from any psychotic symptoms or other psychiatric disorder or substance use disorder (except caffeine & nicotine) assessed through clinical interview using DSM 5 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 History of seizures Pregnancy/ Lactation Uncontrolled medical illness (including hypertension) History suggestive of space occupying brain lesion or cerebrovascular accident Prescription of any antipsychotic medication or mood stablizers History of receiving any neuromodulation therapy (e.g., ECT, rTMS, tDCS) within the last 3-months. Currently receiving any form of Cognitive Behavioral Therapy or any other Psychotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and effectiveness of adjuvant intravenous Ketamine infusion in patients with depression using randomized double-blind comparison with intravenous normal saline infusionTimepoint: 1. Post session, evaluation with outcome parameters (after 40 (+20) min of intervention) - HAMD, HAMA, KSET 2. Post-intervention (after 4 weeks and 8 weeks of recruitment (± 2-3 days)) Evaluation with outcome parameters - HAMD, HAMA, KSET, BDNF level, fNIRS, qEEG. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the change in serum BDNF levels, prefrontal hemodynamic activity (using fNIRS) and spectral/ERP changes (using qEEG) in individuals with depression after adjunctive treatment with normal saline or ketamine infusionTimepoint: At baseline before the intervention and at 4 and 8 week of recruitment (±2-3 days) | — |
Countries
India
Contacts
Public ContactSharaz ahmed
All India Institute of Medical Sciences New Delhi
Outcome results
None listed