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Clinical trial

A Multi-center, Randomized, Double-blind, Parallel Group, Placebo-controlled 52 Weeks Clinical Trial to Evaluate Efficacy and Safety of Oxcarbazepine p.o.(300-1200 mg/Day) as Adjuvant Therapy in the Bipolar Disorder I or II Treatment

ID
Name
CTRI476BES03
Description
Bipolar disorder is a psychiatric illness with clinical characteristics of mixed mania, grandiose delusions, and suicidality. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of patients with bipolar disorder type I or II.
Trial arms
Trial start
2003-01-01
Estimated PCD
2006-01-01
Trial end
2006-01-01
Status
Completed
Phase
Early phase I
Treatment
Oxcarbazepine
Size
55
Primary endpoint
Duration of remission
Eligibility criteria
Inclusion Criteria: * History of bipolar disorder type I or II Exclusion Criteria: * Other serious medical conditions * Treatment with antiepileptic medications Other protocol-defined inclusion/exclusion criteria may apply.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE'}}, 'enrollmentInfo': {'count': 55, 'type': 'ACTUAL'}}
Updated at
2023-12-14

1 organization

1 product

1 indication

Organization
Novartis
Product
Oxcarbazepine
Indication
Bipolar Disorder