MedPath

Therapeutic Efficacy of Oxcarbazepine and Sodium Valproate in Acute Mania

Phase 3
Conditions
acute mania.
Mania without psychotic symptoms
Registration Number
IRCT201012055280N2
Lead Sponsor
Mashhad University of Medical Scinces
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
48
Inclusion Criteria

For eligibility in the study patients had to be 18 to 60 years of age and with DSM- IV- TR axis I diagnosis of BMD-I in acute manic episode.
Exclusion criteria included a primary diagnosis of Schizophrenia, delirium, anorexia nervosa, bulimia, autism, substance abuse, mental retardation and ADHD in recent 3 months. Other exclusion criteria were a history of epilepsy, a history of psychogenic polydipsia, a history of symptomatic hyponatremia and patients who were taking other antimanic medications during the study prior or within one week before it. Patients were required to be free of psychotropic drugs with exceptions of diphenhydramin or lorazapam for control of agitation and aggression. Risperidone 2-4 mg/day was prescribed for all of patients.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change of mood. Timepoint: base line,weeks 3,6. Method of measurement: Young Mania rating scale.
Secondary Outcome Measures
NameTimeMethod
Clinical Global Impression Scale. Timepoint: base line ,weeks 3 and 6. Method of measurement: change of scores.
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