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A comparative study on the effect of loading dose of lithium carbonate+ Quetiapine and standard dose of lithium carbonate+ Quetiapine on acute mania

A comparative study on the effect of loading dose of lithium carbonate+ Quetiapine and standard dose of lithium carbonate+ Quetiapine on acute mania

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181204041847N2
Enrollment
60
Registered
2023-08-16
Start date
2023-05-15
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar 1 disorder (acute manic phase). Bipolar disorder, current episode manic severe with psychotic features

Interventions

Intervention 1: Intervention group: receive loading dose of lithium carbonate (20 mg/kg) in form of a stat dose. Intervention 2: Control group: this group receives routine dose of Lithium carbonate (3

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Grades on basis of Young mania rating scale (YMRS). Timepoint: days: 0- 3-7-14. Method of measurement: (YMRS)Young mania rating scale.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEbrahim Moghimi Sarani

Shiraz University of Medical Sciences

moghimiebrahim@yahoo.com+98 71 3228 9601

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026