Health Condition 1: F313- Bipolar disorder, current episodedepressed, mild or moderate severity
Conditions
Interventions
Intervention1: A single blinded randomised controlled trial to determine the relative efficacy and safety of low dose cariprazine: Group A will be recieving low dose cariprazine 1.5-3mg per day by or
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 acute bipolar-II depression as per ICD-11 criteria. 3. Patients who will be medically stable. 4. Patients who will be accompanied by reliable informants. 5. Patients and informants who give written informed consent and are willing participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients who have associated medical illness, which could affect the course of illness e.g., T2DM, hypertension, pulmonary/cardiovascular/renal illnesses. 2. History of substance use disorder in the last six months. 3. Patient on other psychiatric medication which may interfere in assessing treatment response by the principal drug:- a. Mood stabalizers, e.g., Lithium, Divalproex, Carbamazepine, Lamotrigine. b. Other Antipsychotics, e.g., Quetiapine, Lurasidone, Risperidone, Amisulpiride, etc. c. Other Antidepressants, e.g., SSRIs other than Fluoxetine, SNRIs and atypical antidepressants. For this purpose, a 2-week washout period for any of the above drugs will be carried out with the permission and written consent of patient and caregiver. 4. Any other co-morbid psychiatric illness. 5. Patients requiring multiple psychotropics (except adjunct medication i.e. BZD/ Propranolol). 6. Pregnant and Breastfeeding females. 7. Patients with Intellectual disability. 8. Patients with history of epilepsy, or other organic/ neurological disorder. 9. Hypersensitivity to low-dose Cariprazine or OFC as applicable. 10.Refusal to give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the therapeutic efficacy of low-dose Cariprazine and OFC in acute bipolar-II depressionTimepoint: Therapeutic efficacy will be determined in the visit one(baseline), week 2, week 4, week 6, week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the at-risk metabolic factors in terms of side effect profile due to low dose Cariprazine anTimepoint: Therapeutic efficacy will be determined in the visit one(baseline), week 2, week 4, week 6, week 8 | — |
Countries
India
Contacts
Public ContactDr Rohit garg
Government medical college and Rajindra hospital Patiala
Outcome results
None listed