A comparative study on the effectiveness of Electroconvulsive therapy and ketamine in person suffering from depressive disorder not responding to medications
Not Applicable
Completed
- Conditions
- Health Condition 1: F322- Major depressive disorder, singleepisode, severe without psychotic featuresHealth Condition 2: null- treatment resistant depression
- Registration Number
- CTRI/2020/08/027340
- Lead Sponsor
- Ahana hospitals LLP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 96
Inclusion Criteria
1.Age range 18-60 years
2.Male and Female
3.Written informed consent.
4.Presence of Major Depressive Disorder as per DSM V guidelines
5.Refractory to at least two anti-depressant medications
Exclusion Criteria
1. Co-morbid psychiatric diagnoses such
as psychosis, bipolar disorder, substance dependence (including nicotine dependence)
2. Mental retardation, neurological disorders and severe medical illness
3. pregnancy or breast feeding
4.Diagnosis of major depressive disorder with psychotic features during the current depressive episode
5.allergy to ketamine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 2-3 weeks ] <br/ ><br>Response is defined as at least a 50% improvement in Baseline QIDS-SR-16 score at End of Treatment Visit. The End of Treatment Visit will occur 3-5 weeks after the Baseline Visit. <br/ ><br>Timepoint: baseline and 2-3 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method clinician reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks ] <br/ ><br>Number of patients with an improvement in their Baseline MADRS score at the End of Treatment Visit. The End of Treatment Visit will occur 2-3 weeks after the Baseline Visit. <br/ ><br>Timepoint: baseline and 2-3 weeks