Health Condition 1: F313- Bipolar disorder, current episodedepressed, mild or moderate severity
Conditions
Interventions
Intervention1: Lurasidone: Lurasidone in dose range 20-40 mg will be given in one group at 0 weeks, 6 week with washover period 2 weeks and then at interval of 8 weeks and 14 weeks
Control Interventio
Sponsors
Government medical college patiala
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female patients aged 18-65 years with patient fulfilling DSM 5 criteria for bipolar II depression. 2. Patients who will be medically stable . 3. Patients who have given written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with history of epilepsy, mental retardation or any other organic disorder. 2. Pregnant women and lactating mothers. 3.History of seizures, renal insufficiency or congestive heart failure. 4.History of drug abuse and dependence in the last six months. 5. Refusal to give informed consent 6. History of hypesenstivity/rash/bronchial asthma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure will be early response to treatment by improvement in severity of depression on HRSD, response will be more than 50% improvement on Ham D, remissions score HRSD 7 ,improvement in impulsivity in BIS and improvement in sleep quality on PSQI and Clinical global improvement on CGI-BP scale. Alda scale measures improvement during course of treatment and score of more than 7 is for treatment response.Timepoint: Data will be collected at 0 weeks, 6 weeks , 8 weeks and 14 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures will be improvement in risk of suicidality on C-SSRS, adverse events on ADR and improvement in quality of life on SF-36.Timepoint: 0 week, 4 week , 8 week and 16 week | — |
Countries
India
Contacts
Public ContactDr Rajnish Raj
Head of department of psychiatry department
Outcome results
None listed