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An interventional study to see outcome by comparing efficiency and safety of two drugs i.e. of levetiracetam versus oxcarbazepine in management of bipolar disorder.

A randomized, open label trial to compare efficacy and safety of levetiracetam versus oxcarbazepine in management of bipolar disorder. - nil

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065780
Enrollment
98
Registered
2024-04-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: F316- Bipolar disorder, current episodemixed

Interventions

Intervention1: Levetiracetam: Tablet Levetiracetam 500/750/1000 mg twice daily for indication for management of bipolar disorder for 12 weeks. Control Intervention1: Oxcarbazepine: tablet oxcarbazepin

Sponsors

Uttar Pradesh University of Medical sciences Department of Pharmacology and Psychiatry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Meet ICD -10 criteria. No previous history of psychiatry illness

Exclusion criteria

Exclusion criteria: Any Pregnant or nursing mother Unstable or uncontrolled cardiovascular disease Evidence of recent ischemic event Hypertension or metabolic disorder Any history of seizure disorder or ischemic stroke Any malignancy

Design outcomes

Primary

MeasureTime frame
reduction in mood episodes as well as the time recurrence of mood episodes the study may find the one drug to be superior or equivalent to the other in terms of efficacyTimepoint: baseline 3rd week 6th week 9th week 12th week

Secondary

MeasureTime frame
Secondary outcome measures could include the improvement in quality of life such as functioning or cognitive performance It is expected that both drugs will improve these outcomeTimepoint: baseline 3rd week 6th week 9th week 12th week

Countries

India

Contacts

Public ContactDr Vishesh Kumar

UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES (UPUMS)

cvsingh.singh@gmail.com9927791470

Outcome results

None listed

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