Health Condition 1: F316- Bipolar disorder, current episodemixed
Conditions
Interventions
Intervention1: divalproex plus aripiprazole.: divalproex will be given in the range of 1000-1500mg/day, od/bd, orally for the duration of study( 8 weeks). Aripiprazole 1.25-5mg will be given in the ra
Sponsors
Government Medical College Patiala
Eligibility
Inclusion criteria
Inclusion criteria: 1-Both males and females aged 18-65 years. 2-Primary diagnosis of Depression with mixed features based on Koukopolous diagnostic criteria. 3-Diagnosis of mild-severe Depression with mixed features defined by KMDRS score 10-21. 4-Ability to remain on adequate stable regimen (on & off label treatment) for >6 weeks. 5-Medically stable for study participation. 6-Participants who will give voluntary informed consent.
Exclusion criteria
Exclusion criteria: 1-History of chronic psychosis or drug induced psychosis of any kind. 2-Currently, DSM-5 diagnosis of drug abuse/dependence in the last six months and has a negative drug screen at baseline. 3-Women will be excluded if they are pregnant, lactating or neither surgically sterile nor using appropriate methods of birth control. Women must agree to continue using applicable birth control throughout the trial. • History of seizures, renal insufficiency or congestive heart failure. 4- History of clinically significant violence. 5- History of hypersenstivity/rash/bronchial asthma. 6-Current alcohol abuse or dependence. 7-Untreated hypertension (Systolic B.P >130mmHg and/or Diastolic B.P >80mm Hg. 8-Clinically, abnormal liver function tests (LFTs), thyroid, renal function or anemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response will be 50% improvement on Koukopoulos diagnostic criteria, Hamilton depression rating scale, Clinical global impression scale- impression, severity.Timepoint: Response will be 50% improvement on Koukopoulos diagnostic criteria, Hamilton depression rating scale, Clinical global impression scale- impression, severity. | — |
Secondary
| Measure | Time frame |
|---|---|
| improvement in quality of life on SF-36 scale & Columbia suicide severity rating scale.Timepoint: baseline, 2, 4, 6 weeks | — |
Countries
India
Contacts
Public ContactDr Rajnish Raj
Government Medical College, Patiala.
Outcome results
None listed