Ketamine vs ECT in patients with severe depression.
Phase 2
- Conditions
- Health Condition 1: F314- Bipolar disorder, current episodedepressed, severe, without psychotic featuresHealth Condition 2: F332- Major depressive disorder, recurrent severe without psychotic featuresHealth Condition 3: F322- Major depressive disorder, singleepisode, severe without psychotic features
- Registration Number
- CTRI/2022/11/047630
- Lead Sponsor
- KLES ACADEMY OF HIGHER EDUCATION AND RESEARCH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients aged between 18 years to 65 years with
1. ICD-10 DCR diagnosis of
a. Severe Depressive Episode without psychotic symptoms.
b. Bipolar affective disorder, current episode severe depression without psychotic symptoms.
c. Recurrent Depressive disorder, current episode severe depression without psychotic symptoms.
2. Availability of an informed consent.
Exclusion Criteria
1.Severe depression with psychotic symptoms.
2.Primary psychotic disorder.
3.Mixed episode
4.Intellectual Disability
5.Dementia
6.Mood disorder due to general medical conditions.
7.Hypertension (with B.P. > 140/90 mmHg)
8.Glaucoma
9.History of seizures, raised intracranial tension
10. Pregnant and lactating females.
11.Serious medical condition.
12.Substance dependence.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 50% reduction in 17-item Hamilton Depression rating Scale, over a course of 3 interventions done 48 hours apartTimepoint: day 2, day 4, day 6
- Secondary Outcome Measures
Name Time Method Reduction in 17-item Hamilton Depression rating Scale, 24 hours after interventionTimepoint: Day 2, Day 4, Day 6