Immediate antidepressant response of oral ketamine versus IV ketamine in depression
- Conditions
- Major depressive disorder, singleepisode, severe without psychotic features,
- Registration Number
- CTRI/2020/09/027644
- Lead Sponsor
- Dr P N Suresh Kumar
- Brief Summary
Severe depressivedisorder is among most debilitating condition. Conventional pharmacotherapyusually takes usually 4–12 weeks to improve symptoms. Ketamine is an N–methyl-Daspartate receptor antagonist having rapid action on depressive symptoms. The objective of the present study is to compare sub-anaesthetic dose of oral versus intravenous ketamine in the acuteantidepressant response in treatment resistant depression in an open labelstudy design.
Sixty drug-free/naïvepatients of either sex, with severe depression having no previous history ofpsychotic disorder, head injury, organic disorder, cardiac problem, orsubstance abuse will be randomly assigned to either oral or intravenous ketamine.All of them will be allowed to continue existing medications without anychanges in dose. Assessments will be made at baseline, day 3, day 5, day 7, day 9, day 11, day 13 and after 1 monthusing Hamilton Depression Rating Scale, Montgomery Asberg Depression RatingScale, BeckDepression Inventory, and Clinical GlobalImpressions (CGI) Scale. The two groups will be compared on various aspects tofind out whether there is any significant difference in the efficacy as well astolerability.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
- 1 Failed 2 trial of different antidepressant class of adequate dose and duration.
- 2 Current depressive episode is of at least 4 weeks duration.
- 3 Not received ECT at least prior to enrollment.
- 1 Other psychiatric disorders.
- 2 Pregnancy and lactation.
- 3 Concurrent major life-threatening illness like malignancy, cardiac failure, renal failure etc.
- 4 Alcohol and substance abuse and smokers.
- 5 Patients with electrocardiogram abnormality or abnormality on fundoscopy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change in clinical ratings of depression in Hamilton Depression Rating Scale Day 0,3,5,7,9,11,13
- Secondary Outcome Measures
Name Time Method Changes in Montgomery Asberg Depression rating scale and Clinical Global Impression of severity and Improvement Day 0,3,5,7,9,11,13 and 1 month
Trial Locations
- Locations (1)
IQRAA Psychiatric care and rehabilitation centre
🇮🇳Kozhikode, KERALA, India
IQRAA Psychiatric care and rehabilitation centre🇮🇳Kozhikode, KERALA, IndiaDr P N Suresh KumarPrincipal investigator9447218825drpnsuresh@gmail.com