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Therapeutic Efficacy of Oxcarbazepine and Sodium Valproate in Acute Mania

Therapeutic Efficacy of Oxcarbazepine and Sodium Valproate in Acute Mania

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201012055280N2
Enrollment
48
Registered
2011-02-18
Start date
2009-07-04
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

acute mania. Mania without psychotic symptoms

Interventions

Intervention 1: In the first group, during the 2 weeks titration phase, the Oxcarpazepine was started by 300 mg and increased every 2 days to a maximum dose of 900 to 2400 mg per days or the highest t
Treatment - Drugs
In the first group, during the 2 weeks titration phase, the Oxcarpazepine was started by 300 mg and increased every 2 days to a maximum dose of 900 to 2400 mg per days or the highest tolerated dose.
In the second group, Na Valporate was initiated by 600 mg/day and increased to a 20-36 mg/day or the highest tolerated dose for patients.

Sponsors

Mashhad University of Medical Scinces
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Change of mood. Timepoint: base line,weeks 3,6. Method of measurement: Young Mania rating scale.

Secondary

MeasureTime frame
Clinical Global Impression Scale. Timepoint: base line ,weeks 3 and 6. Method of measurement: change of scores.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ali Talaei

Psychiatry and Behavioral Sciences Research Center, Ibn-e-Sina Hospital, Mashhad University of Medic

talaeia@mums.ac.ir , alitalaei@gmail.com+98 51 3711 2540

Outcome results

None listed

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