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Various medicines for treatment of acute manic episode

Comparative efficacy of Lithium, Valproate and Antipsychotic in acute manic episode (LVAM) - LVAM

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/060311
Enrollment
75
Registered
2023-11-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Health Condition 1: F311- Bipolar disorder, current episodemanic without psychotic features

Interventions

Intervention1: Lithium: 1. Lithium : Dose (ranging 600-1500 mg) required to attain serum levels of 0.8mEq/L to 1.0mEq/L will be given till discharge up to 3-4 weeks. Intervention2: Antipsychotics ::

Sponsors

Ajeet Sidana Government Medical College Hospital(GMCH) Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis of Mania (BPAD current episode mania with or without psychotic symptoms), as per ICD 11. 2. Must be off medications for 2 weeks. 3. Any gender aged 18-60 years.

Exclusion criteria

Exclusion criteria: 1. Patients uncooperative for assessment. 2. Patients with comorbid intellectual disability, dementia or organic brain syndrome. 3. Presence of comorbid severe and unstable medical/surgical illness. 4. Acutely suicidal patients 5.Pregnant and lactating females 6.Patients with hypersensitivity to lithium, valproate and antipsychotics

Design outcomes

Primary

MeasureTime frame
To assess the efficacy of pharmacological treatment options in hospitalized patients with mania.Timepoint: YMRS-48 hourly for first week, at Discharge. BPRS-Daily for first week, at Discharge Side effects Checklist-Daily till discharge

Secondary

MeasureTime frame
To study the effect of treatment on duration of resolution of symptoms and duration of hospitalization. Timepoint: 2-4 weeks

Countries

India

Contacts

Public ContactAjeet Sidana

Government Medical College Hospital (GMCH)

ajeetsidana@hotmail.com9056422679

Outcome results

None listed

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