Health Condition 1: F313- Bipolar disorder, current episodedepressed, mild or moderate severity Health Condition 2: F314- Bipolar disorder, current episodedepressed, severe, without psychotic features
Conditions
Interventions
Intervention1: Ketamine infusion: Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Sub-anesthetic (low) doses will be given to patients via infusion
Sponsors
Ahana hospitals LLP
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) â?? approximately 7th day] 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. Timepoint: Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) â?? approximately 7th day] 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| clinician reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 7th day ] 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. Timepoint: baseline and 7th day | — |
Countries
India
Contacts
Public ContactVikhram Ramasubramanian
Ahana hospitals, LLP
Outcome results
None listed