Health Condition 1: F318- Other bipolar disorders
Conditions
Interventions
Intervention1: Metformin: Group A consisting of 62 patients will be given Metformin 1000mg daily for 24 weeks. Patients will be assessed based on parameters like weight, body mass index, waist circumf
Sponsors
Government Medical College Patiala Punjab
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients in the age group of 18 to 65 years. 2.Patients suffering from Bipolar-2 depression as per ICD-11 criteria. 3.Patients who will be medically stable. 4.Patients who will be accompanied by reliable informants. 5.Patients who develop Olanzapine-fluoxetine combination induced weight gain as established by Naranjo’s causality scale. 6.Patients and informants who give written informed consent and are willing participate in the study and take Tab Metformin and Tab Dapagliflozin as weight loss agents for Bipolar-2 depression.
Exclusion criteria
Exclusion criteria: 1.Patients who have associated medical illness, which could affect the course of illness eg. Type 2 diabetes mellitus, hypertension, pulmonary/cardiovascular/renal/thyroid illnesses. 2.History of substance use disorder in the last six months. 3.Patient on other psychiatric medication known to increase weight. A.Mood stabalizers: Lithium, Divalproex B.Antipsychotics: Quetiapine, Clozapine, Risperidone. 4.Any other co-morbid psychiatric illness. 5.Patients requiring multiple psychotropics (except adjunct medication i.e. Benzodiazepines/ Propranolol). 6.Pregnant and Breastfeeding females. 7.Intellectual disability patients. Patients with history of epilepsy, or other organic disorder. 8.Contraindication to use of Metformin e.g. Hypersensitivity etc. 9.Contraindication to use of Dapagliflozin e.g. Hypersensitivity, Urinary tract infections (UTIs) etc. 10.Refusal to give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate physical parameters including weight, body mass index, waist circumference and blood pressure in patients on antipsychotics and to compare lab investigations including fasting blood sugar, fasting lipid profile and glycated hemoglobin.Timepoint: outcome will be assessed in four readings at baseline, 4 weeks, 12 weeks and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare illness severity by bipolar depression rating scale score and clinical global impression – bipolar illness score, Quality of life on world health organization quality of life brief version score and adverse events on adverse drug reaction scale. Timepoint: outcome will be assessed in four readings at baseline, 4 weeks, 12 weeks and 24 weeks | — |
Countries
India
Contacts
Public ContactRohit Garg
Government Medical College, Patiala
Outcome results
None listed