Study on the effectiveness of Ketamine in persons suffering from bipolar depressio
Not Applicable
- Conditions
- Health Condition 1: F313- Bipolar disorder, current episodedepressed, mild or moderate severityHealth Condition 2: F314- Bipolar disorder, current episodedepressed, severe, without psychotic features
- Registration Number
- CTRI/2021/10/037093
- Lead Sponsor
- Ahana hospitals LLP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Written informed consent.
Patients diagnosed with bipolar affective disorder current episode depression as per ICD 10 guidelines
Patients started on antidepressants specifically SNRIs
Exclusion Criteria
Co-morbid psychiatric diagnoses such
as psychosis, substance dependence
Mental retardation, neurological disorders, and severe medical illness
Pregnancy or breastfeeding
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) â?? approximately 7th day] <br/ ><br>Response is defined as at least a 50% improvement in Baseline HAM-D score at End of Treatment Visit. The End of Treatment Visit will occur 7th day after the Baseline Visit. <br/ ><br>Timepoint: Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) â?? approximately 7th day] <br/ ><br>Response is defined as at least a 50% improvement in Baseline HAM-D score at End of Treatment Visit. The End of Treatment Visit will occur 7th day after the Baseline Visit. <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 7th day ] <br/ ><br>Number of patients with an improvement in their Baseline CGI score at the End of Treatment Visit. The End of Treatment Visit will occur in 7th day after the Baseline Visit. <br/ ><br>Timepoint: baseline and 7th day