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Clinical Trials/CTRI/2024/09/073722
CTRI/2024/09/073722
Not yet recruiting
Phase 2

Comparison of the rapid anti-depressant effects of Ketamine vs Thiopentone assisted Modified Electro Convulsive Therapy in patients with Severe Depression-A hospital based Randomised Control Trial.

Dr Jaya Rama Rao Ponnamanda1 site in 1 country24 target enrollmentStarted: September 20, 2024Last updated:
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Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Dr Jaya Rama Rao Ponnamanda
Enrollment
24
Locations
1
Primary Endpoint
To compare the rapid anti-depressant effects of Ketamine assisted vs thiopentone assisted modified ECT
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This study aims to compare the rapid anti depressant effects and Cognitive effects of Ketamine Vs Thiopentone assisted modified Electro Convulsive therapy(ECT) in patients with Severe Depression. Thiopentone is the routinely used drug for induction in Modified ECT. Ketamine is a newer drug which is widely known for it rapid antidepressant properties. This study will use Ketamine as an induction agent in one arm and compare the antidepressant effects and effect in cognitive decline compared to Thiopentone which will be used in the other arm.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Single Episode Depressive disorder, severe, without psychotic symptoms.
  • •Recurrent depressive disorder, current episode severe, without psychotic symptoms.
  • •Bipolar Type I disorder, current episode depressive,severe without psychotic symptoms.
  • •Bipolar Type II disorder, current episode depressive, severe without psychotic symptoms.

Exclusion Criteria

  • •Severe depression with presence of psychotic symptoms -Primary psychotic disorder.
  • •Mixed episode.
  • •Pregnant and Lactating females.
  • •Severe medical conditions such as Renal failure, Hypertension, IHD.

Outcomes

Primary Outcomes

To compare the rapid anti-depressant effects of Ketamine assisted vs thiopentone assisted modified ECT

Time Frame: 1 year

Secondary Outcomes

  • To compare the cognitive effects in patients who have reveived Modified ECT under Ketamine and Modified ECT under Thiopentone(1 year)

Investigators

Sponsor
Dr Jaya Rama Rao Ponnamanda
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Jaya Rama Rao Ponnamanda

Jawaharlal Nehru Medical college

Study Sites (1)

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