A comparative study on the effect of loading dose of lithium carbonate+ Quetiapine and standard dose of lithium carbonate+ Quetiapine on acute mania
Phase 3
- Conditions
- Bipolar 1 disorder (acute manic phase).Bipolar disorder, current episode manic severe with psychotic featuresF31.2
- Registration Number
- IRCT20181204041847N2
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
known cases of Bipolar type 1 disorder (B1D)
Acute manic phase
No consumption of lithium carbonate since at least ten days ago.
Exclusion Criteria
patients with each kind of cardiac conditions or any positive past history of cardiac diseases- any abnormal findings in their first ecg during this admission(arrhythmia, ST change,...)
positive history of psoriasis
hypothyroidism or hyperthyroidism
cases of chronic kidney disease or acute kidney injury
any allergy or history of anaphylaxis with lithium carbonate
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Grades on basis of Young mania rating scale (YMRS). Timepoint: days: 0- 3-7-14. Method of measurement: (YMRS)Young mania rating scale.
- Secondary Outcome Measures
Name Time Method Ecg change. Timepoint: pre medication (day 0), day 3, day 7, day 14. Method of measurement: any ecg change in comparison with baseline.;Renal function. Timepoint: day 0,5,10. Method of measurement: serum bun, cr.;Serum lithium level. Timepoint: day 0,7,14. Method of measurement: serum lithium lab test.